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RISPERIDONE 2MG TABLETS USP — Aripiperazole Tablets10 mg Taj Pharma

Anti Cancer

Patients worldwide rely on Taj Pharma’s Anti-Cancer products to meet their medical needs. Ensuring an unrestricted supply of safe medicines is of critical importance to us, and doing so requires a secure, accountable supply chain of trusted partner companies. In 2018, Taj Pharma Oncology division completed audits of 9,892 suppliers globally, and more than 11,000 supplier audits were planned for 2019.

Anti Cancer Products (Taj Oncology)

Taj Anti Cancer Division is leading manufacturer of generic oncology products and biosimilars. Through its broad portfolio of products in Taj Pharma basket, dedicated oncology subsidiary is most innovative integrated portfolio with focus on affordability of quality products to treat cancer and help patients to see a ray of hope, we constantly strive to make high quality oncology products that offer treatment to cancer patients and improve the overall quality of life by reducing healthcare costs.

Pre-Filled Syringes

Taj Pharma Pre filled Syringe Unit is our latest group venture completely dedicated to the development of innovative parenteral drug delivery systems. Established in 2009, TPL PFS Unit is a one-of-its-kind project with modern and state-of-the-art manufacturing facilities.

Critical Care

Critical Care Medicine | The need for patient safety is of the utmost importance. Critical care medicine, or Intensive care medicine, is a branch of Taj Pharmaceuticals concerned with the diagnosis and management of life-threatening conditions that may require sophisticated life support and intensive monitoring.

Speciality

Specialty drugs are high-cost prescription medications used to treat complex, chronic conditions like cancer, rheumatoid arthritis, and multiple sclerosis.

Biosimilars

A biosimilar is a biologic medical product highly similar to another already approved biological medicine (the ‘reference medicine’). Biosimilars are approved according to the same standards of pharmaceutical quality, safety and efficacy that apply to all biological medicines..

About Taj Pharma

Taj Pharmaceuticals is the global leader in generics and one of the India’s top ten pharmaceutical companies. Taj Pharma India play a leading role in therapeutic areas such as cancer, virology and transplantation. The combined strengths of Taj Pharma generics and pharmaceuticals businesses, coupled with expertise in the emerging genetic sciences, equip us to develop integrated healthcare solutions and therapeutic approaches tailored to individual patients’ needs. Taj Pharmaceutical’s products and services address the entire healthcare spectrum, from screening for genetic risk factors, to preventing, diagnosing and treating disease, and monitoring the treatment response.

Taj Pharma India delivers a unique contribution to better healthcare. Taj Pharma India aim to reduce suffering and improve health and quality of life of people all around the world. At Taj Pharmaceuticals, Taj Pharma India have pursued this mission with patience, dedication, imagination and skill, for over a century. Taj Pharma vision is to develop targeted medicines and diagnostic tools that combine to offer patients, physicians and payers better, safer, more cost-effective healthcare.

Once again, welcome to Taj Pharmaceuticals, a great company that is translating a great vision into reality – We Innovate Healthcare.

“Taj Pharmaceutical [Taj Pharma] A Healthcare Pharmaceutical Company”

Taj Pharmaceutical Ltd is a product-driven pharmaceutical company with an expertise as diverse as the stars of our beloved country. While we are relatively not new to the Indian market, so we know all about the littlest of the details that can go around in the healthcare industry.

Taj Pharma product development and manufacturing capability, teamed with our ability to market products in many global markets, makes us an attractive business ally. An integral part of our business strategy is to find such collaborations that not only input their skills and talents but also their vivid experiences. A “Win-Win” strategy that strengthens the position of our partners as well as TPL.

Taj Pharmaceutical(reviews) have already tried our hands on the commercial sector of our industry and have experienced immense success while penetrating the worldwide healthcare market, and it is our absolute honor that Taj Pharma is able to look forward to future business opportunities with the help of strategic business opportunities and meaningful alliances.

Historically health care companies have been mostly about people in lab-coats, behind the bench inventing. It started with talking about generic molecules which is important and we still do that. But we also started talking about services, and now it has moved to show the experience: what do our generic products mean to the person on the other side using them?

Priyanka Singh is the director of Taj Pharma Company, India. She is working in the healthcare provider company for creating a healthier world. She has played a major role in the journey of the Taj Pharma prior to becoming Taj Pharmaceutical group.

Priyanka Singh(taj pharma) contributed a lot to the company’s strategy and philosophy for Africa and the MENA region. She is associated with Smile foundation, UNRWA, UNICEF, and Nepal relief projects so that she keeps contributing medical assistance and other aids for the people.

Abhishek Singh is also an honorary mention in the company’s successful demeanors. He is the CEO of Taj Pharma Company, which is committed to earning the trust of patients, doctors, and customers daily. The Taj Pharmaceutical(reviews) have been developing a new kind of healthcare company in the last ten years.

Our main perspective is to help people live better and longer lives all across the globe.

Taj Pharma: Innovating on the Secret to a Healthy Life

The Taj Pharmaceutical Limited is an Indian based pharmaceutical company. The company has its focus on pharmaceuticals and diagnostics. It is a leader in healthcare groups that are motivated by innovation throughout the world. Due to its interest in research and diagnostics, the Taj Pharma group is leading in the global diagnostics market. The group is known for employability of a population of more than 65 thousand employees. Taj pharma vows to serve its customers with high-quality medicines.

The company has expertise in various fields of medicine. The company is a supplier of products as well as services to help detect, prevent and treat ailments all over the world. The company takes pride in its business strategy of collaboration and strategic alliances. It is an attractive ally in the market because of its development, manufacturing and marketing strengths. The pharmaceutical company manufactures allopathic, ayurvedic as well as generic drugs. It is the leading pharmaceutical supplier of diseases like cancer and HIV. It is a leader in transplant and virology. It is also involved in API research and production.

Taj Pharmaceuticals provides its customers with services to:

Determine disease predisposition
Provide health information so as to act upon any possible threats of illness.
Diagnose disease
Treat Disease

Taj Pharmaceuticals Limited is focused on acquiring the trust of medical specialists, patients and clients consistently. The company has been trying to build a new health care system to be able to build long-term ventures with their stakeholders on Mutual confidence and trust. The company is solely focused on maintaining relationships with clients and partners both, through their show of hard work, integrity, transparency and the production of the best quality drugs.

The Taj Pharmaceutical reviews have been a report of the heights that the company has reached. The company has received excellent reviews from their clients that resonate on the moral background that the company is based on. The success of its marketing strategy and the company’s growth has given the company the motivation to spread its business worldwide and the result is already seen all around.

Taj Pharmaceuticals | Pharmaceutical Company India | Taj Pharma

India is on its way to becoming one of the biggest pharmaceutical producers in the world and many companies import their medicines and other pharmaceuticals from India. The reason being quality medicine being produced at cheaper rates and the comparative lack of red tape means better distribution and taxation policies in the country.

Taj Pharmaceuticals is one of the most prominent Pharma companies in the country and has been ever expansive, becoming a major pharmaceutical force in more than 40 countries across the globe. Taj Pharma is an all-encompassing company with facilities dedicated to research and development, testing and drug manufacturing. As an aspiring leader in pharmacology and pharmaceuticals, Taj Pharma maintains and excels the absolute highest industry standards, which is evident by the number of countries willingly importing their product.

Taj Pharma is a composite of all the above-mentioned operations. The company is wholly dedicated to improving the quality of life of the people dependent on their products for survival. They have operations in every major market in the world and their products are under constant scrutiny by the various regulating bodies all over the world. The stringent multi-level internal quality control is what helps Taj Pharmaceuticals manufacture the highest quality products. Their manufacturing facilities, located in Valsad, Gujarat, and Raigarh, Maharashtra are WHO-GMP approved and subjected to regular inspections by the internal quality control team and the Managing Director (MD). This dedication to maintaining and exceeding quality regulations is what sets them apart from their peers.

Their products cover a plethora of generic and branded compositions catering to a multitude of consumers all over the world. The exemplary work done by Taj Pharmaceuticals(Reviews) has made them a trusted household name. They are constantly striving for excellence which is evident by their Research and Development facilities which are always willing to tackle new challenges.

Taj Pharma is not just a pharmaceuticals company. It is a vision; a vision to provide quality health care for everyone, to alleviate the suffering of people and to promote excellence in all spheres by giving access to the best and most well-researched products modern science has to offer says Abhishek Taj Pharma.

[Taj Pharma] India | One of the Reputed Pharma Company all across the World

Taj Pharmaceuticals Limited is a well-known Indian pharma company which manufactures medicines and drugs. It is actually a research-based company, which does research with different chemicals and natural herbs and then manufactures medicines and drugs. The company has its head office in India as well as it has established offices in many foreign countries also. Taj Pharmaceuticals Limited manufactures medicines and drugs in India and exports them to 81 countries of Asia, Africa, America, Europe, and Australia. The medicines and drugs manufactured by Taj Pharma are widely used and recommended by many doctors worldwide.

Taj Pharma manufactures medicines and drugs for several diseases, common and fatal, like Anemia, Anxiety Disorders, Cancer / Oncology, Ear Infections, Heart Failure, Hepatitis, HIV / AIDS, Influenza, Non-Hodgkin’s Lymphoma, Obesity, Osteoporosis, Parkinson’s disease, Pneumonia, Hepatitis A, Typhoid, Polio, Japanese Encephalitis, Hepatitis B, Rabies, Tetanus-Diphtheria, Diarrhea etc. Some of these medicines are made after numerous attempts of experiments and research. And the medicines manufactured or produced, at Taj Pharma India, have a good quality and effect. This has made Taj Pharmaceuticals reach the new heights of success.

The success that Taj Pharma has achieved today is because of the sheer efforts of its core team. Taj Pharmaceutical Directors– Abhishek Singh and Priyanka Singh. Mr. Abhishek Singh is the Managing Director of Taj Pharma Company while Priyanka Singh is the Export Director. Both these people are owners of Taj Pharmaceuticals and therefore are addressed as Mr. Abhishek Taj Pharma MD and Ms. Priyanka Singh Taj Pharma MD.

Both the directors are the children of the Founder and Chairman of Taj Pharmaceuticals Limited, Dr. R K Singh. The reins of the company are in the hands of Taj Pharmaceutical Directors and the Chairman completely. They have taken care of the smallest things too so as to avoid any kind of risk and provide the best quality medicines. It is the dedication and hard work of the Directors- Mr. Abhishek Singh and Ms. Priyanka Singh which has made the company one of the trusted pharma brands in the world.

Taj Pharmaceuticals | Pharmaceutical Company India | Taj Pharma

Pre-Filled Syringes

We also develop manufacture and commercialise Pre-Filled Syringes (PFS) used principally for the emergency treatment of cardiac arrest.

PFS offer significant benefits over the traditional « vial and syringe » format, by increasing dosing accuracy, safety and convenience. The usage of PFS in Critical Care is increasing at hospitals and in ambulances for many reasons such as

Avoiding mistakes during administration
Providing fast medication
Risk reduction related to preparation drug
Economic interest comparing waste of syringe prepared
Nursing time saving

Pre-Filled Syringes

We also develop manufacture and commercialise Pre-Filled Syringes (PFS) used principally for the emergency treatment of cardiac arrest.

Avoiding mistakes during administration
Providing fast medication
Risk reduction related to preparation drug
Economic interest comparing waste of syringe prepared
Nursing time saving

Our Range of Pre-Filled Syringes comprises 90 products and has been designed to enhance ease of use and help improve patient safety in case of cardiopulmonary resuscitation or in the operating theatre environment.

Production Facilities Pre-Filled Syringes

Taj Pharma Pre-Filled Unit is a group venture of Taj Pharma group.

Taj Pharma PFS unit is our latest group venture completely dedicated to the development of innovative parenteral drug delivery systems. Established in 2009, TPL is a one-of-its-kind project with modern and state-of-the-art manufacturing facilities. TPL excels in:

1. Manufacturing empty glass pre-fillable syringes

2. Formulating glass as well as plastic pre-filled syringes

With a production capacity of 1,50,000 syringes per day, TPL PFS unit is all set to be a global leader in its field of specialization, i.e., formulation and manufacture of exclusive pre filled syringes that meet all quality standards.

At TPL, we adhere to strict norms and certifications. The manufacturing facility complies with the all international regulations of US FDA, MHRA, and WHO GENEVA, etc.

With a vision to conquer new horizons of excellence, TPL’s strength lies in its use of top quality equipment and its experienced professionals. The entire manufacturing process is automated to guarantee zero contamination. From the loading of glass tubes to obtaining the final formulated syringe, there is absolutely no human intervention at any level.

At TPL, we believe in delivering the best, and nothing but the best! We make use of world class lab equipment, superior processing machines, cleanrooms, air handling systems and the best laboratory practices. With aid of our in house R & D facility, we select the best raw materials and components for the syringes to ensure quality par excellence.

If you are looking for an integrated solution to your entire parenteral drug delivery needs, your search ends at TPL.

Production Facilities

TPL has earned national as well as international acclaim for its remarkable production facilities. Here is why:

• WHO-GMP Certificate acquired.

• One of the few facilities in the country with capabilities for manufacturing and formulating pre-filled syringes.

• Comprehensive and diverse formulation sections: General, Beta lactum, Hormones, Oncoloy, etc.

• Computerized and automated process; no human touch at any level.

• Dedicated line for general products with large market stakes.

• Compliance with all international regulatory bodies: MHRA, US FDA, WHO GENEVA, etc.

• Continuous online monitoring and inspection at every step.

• Installation of 17 pre-filled syringe filling lines that function with negligible error.

• Capabilities for filling both glass and plastic syringes.

Empty Glass Prefilled Syringes

We manufacture premium quality glass pre-filled syringes which satisfy all customer requirements in toto. Their flexible design features allow optimal and easy incorporation of individual components. They are also technically compliant with all international standards in the pharmaceutical and medical device industry.

Our range comprises of:

• Sizes from 0.5 to 5ml

• Staked needle and Luer Lock syringes

• Pharmaceutical rubber formulations with variants

• All relevant interior tampering options

• Printing options

• Customized delivery forms

We can supply glass pre-fillable syringes both as bulk products and as ready for filling format: washed, siliconized, pre-assembled and sterilized in compliance with all international regulations. We have a patented trademark for our glass syringe systems and components.

At TPL, we are focused on application safety at every stage. Needle shields with thermoplastic elastomers protect the needle point from deformation before the injection. These shields also ensure the essential sharpness of the needle. They reduce the risk of needle-staked injuries to a great deal. Tamper-evident Luer lock closure with a guided twist-off action is a salient feature of our product. Our empty glass pre-filled syringes are manufactured in a completely sterile and protected environment in an automated process with no human touch at any stage. They are compatible with all existing filling machines.

Our Branded Formulations

TPL is poised to redefine parental drug administration systems in terms of safety, stability and convenience. For this purpose, all our products are available in prefilled syringe form. We have also succeeded in overcoming the challenge of biocompatibility with the syringes of glass and plastic owing to our accomplished R & D team.

We highly recommend the use of our pre-filled syringes, the future of parental drug delivery and medications. Our syringes offer immense benefits over the conventional forms of injectable. To enlist a few:

The benefits are as follows

No chance of contamination from hand or from hospital atmosphere.

Saving valuable time in critical care management since the primary container of medication is the syringe itself.

Easy to administer.

Accurate dosage.

Eliminates human errors of wrong choice of medication in an unmarked syringe that frequently occur during an emergency.

Minimal chance of needle injury to the healthcare staff.

Minimizing medical wastage to a great deal by rendering vials and ampoules unnecessary and hence their production, avoidable.

Currently in the domestic market, we offer parental therapeutic solutions in the following product segments:

Cardiac critical care.

Anesthesia.

Gynecology.

General.

Cardiac Critical care

Anticoagulants, Catecholamine, Parental anti-anginal, Anti arithmetic agents, Sympathomimetic.

Contract Manufacturing

TPL offers the attractive option of Contract manufacturing for your products! Partner with RBL and extend the lifecycle of your product by moving it from ampoules and vials to Roselabs’ Prefilled Syringes!

Life-cycle management is an integral part of the success of a brand. For the pharmaceutical industry in India, its significance is tremendous. Rather than build strong brands, many pharmaceutical companies today depend on their ability to keep the pipeline filled with new products. However, the discovery of new products has been declining, while at the same time development costs have been increasing. Patent laws do not permit reverse engineering, putting Indian companies at a disadvantage.

This is the right time for Indian companies to turn to brand life cycle management. In a hotly contested market such as India, one should opt for sophisticated and advanced drug delivery systems to set themselves apart from the competition. And therefore, for small volume parentals, prefilled syringes become a very attractive option.

End-user-friendly systems such as Roselabs prefilled syringe, cartridge and pen system turn into unique selling propositions for your product, enhancing its attractiveness and its chances of extending the life-cycle.

Roselabs Pre-filled and Pre-fillable Syringes help in:

Differentiation from competition – this will raise your brand to new heights.

Premium pricing possibilities – Economic advantages translate into better profits.

More attractive for end users- Giving your product a new edge.

Will add significant value to the treatment of a medical condition.

We believe in a strong and perpetual partnership with you…

Commercial benefits when you partner with Roselabs:

oselabs Prefilled Syringes offer tremendous savings!

Vial washing, de-pyrogenation, and vial-component preparation equipment are not required because the syringes come pre-sterilized and ready for use.

Enhanced efficiency can be achieved With prefilled syringes, overfilling is less than 2% as opposed to ampoules and vials where it may be over 18%.

Shift from conventional forms of drug delivery to the new Pre-filled technology today! Get your product filled at Roselabs, the one-of-its-kind facility where both manufacturing and the formulation of empty pre-filled syringes are done under one roof.

Avoiding mistakes during administration
Providing fast medication
Risk reduction related to preparation drug
Economic interest comparing waste of syringe prepared
Nursing time saving

Our Range of Pre-Filled Syringes comprises 9 products and has been designed to enhance ease of use and help improve patient safety in case of cardiopulmonary resuscitation or in the operating theatre environment.

Taj Pharmaceuticals manufactures a diverse collection of drugs essential to the management of critically and chronically ill patients, including, but not limited to, anticoagulants, cardiovascular agents, antiemetics, anti-inflammatory agents, and CNS drugs.

We develop, manufacture and commercialise a comprehensive range of critical care products for patients all around the world.

These medicines are used for the specialised care of patients whose condition are life-threatening and require comprehensive care and monitoring.

The infectious disease burden in India is among the highest in the world, and hospital acquired infections are of particular concern due to poor sanitation or merely due to population. These infections pose a great risk to the timely recovery of patients and are associated with high mortality rates. As a result, critical care medicines play a vital role in reducing morbidity and mortality. In addition, critical care patients have life-threatening conditions requiring healthcare professionals to often use a multi-pronged treatment approach that can affect the cost of daily therapy.

To satisfy the unmet medical needs of seriously ill patients in intensive care units, Taj Pharma India launched its Critical Care division in 2008, with several high quality, affordable antifungal and antibacterial therapies.

The 5 primary critical care admission diagnoses for adults*

Respiratory system diagnosis
Acute Myocardial infarction
Intracranial haemorrhage or cerebral infarction
Percutaneous cardiovascular procedure with drug-eluting stent
Septicaemia or severe sepsis without mechanical ventilation

Our broad range of products play a key role in emergency situations

We have a broad range of injectable drugs meant for life-threatening emergencies that require immediate and fast intervention, such as a heart attack, convulsions and hypotension or/and as well in case of poisoning.

These medicines are typically administered at hospital by anaesthesiologists, surgeons or specialists in internal medicine, in theatre, intensive care or high dependency units.
First responders also administer these medicines on the field, in emergency trucks for example.

Our Critical Care products are part of the WHO recommendation list of essential medicines. We serve governmental and no governmental organisations such as MEG (Medical Export Group), IDA Foundation and MSF (Médecins sans Frontières) all around the world.
Our large range of products assist *NGO’s in everyday disaster situations

*NGO – Non Governmental Organisation

Specialty drugs are high-cost prescription medications used to treat complex, chronic conditions like cancer, rheumatoid arthritis, and multiple sclerosis.

Specialty drugs sometimes require special handling and administration (typically injection or infusion), and patients using a specialty drug may need careful oversight from a health care provider who can watch for side effects and ensure that the medication is working as intended.

Specialty drugs might be covered through either medical or prescription drug insurance. How a specialty drug is covered usually depends on where the patient receives the drug. If the patient takes a pill or self-injects the drug at home, it is more likely to be covered through his or her prescription drug benefit. If the patient receives the drug at a doctor’s office or an outpatient clinic, it’s more likely to be covered through the medical benefits portion of his or her health insurance coverage.

High-cost medications are typically priced at more than $1,000 per 30-day supply; including self-administered injectables, professionally administered injectables/ infusions, and oral medications

Biotechnology products
Orphan or Ultra-Orphan drugs
Medications that are included in a specialty therapeutic drug class strategy

Biosimilar development

Inside biosimilar drug development

Taj Pahrma employs a stringent development process that is customized for each biosimilar. To begin, it is imperative that we understand the reference product. To do so, we:

Review the literature on both the disease and the reference product
Use the same scientists and state-of-the-art facilities that manufacture our novel medicines to produce our biosimilar medicines, as their creation requires the same high level of precision

Critical quality attributes (CQAs)
Next, we acquire the reference product and use sophisticated analytical tests to determine its CQAs, which:

Are critical to the safety, efficacy, and pharmacokinetics of the drug
Include, but are not limited to: primary structure, higher-order protein structure, receptor binding and immunochemical properties, stability, biological function, general properties and excipients, attached carbohydrates, and proper molecular folding

Scientists typically evaluate over 100 attributes of the biosimilar in comparison to the reference product, determining which are most important for producing a quality biosimilar. Only the gene sequence of the reference product is known, so it is impossible to exactly replicate the manufacturing process. The attributes of the biosimilar medicine are highly unlikely to ever be identical to those of the reference product. However, the biosimilar is close enough to the reference product to demonstrate that any identified differences have no impact on the clinical attributes of the final product.

Quality clone creation
Taj Pharma has the deep scientific capabilities needed to create and select a promising clone from literally thousands of cells. The optimal clone produces the antibody that matches the biological function of the reference product as closely as possible, promoting the development of a biosimilar that has no clinically meaningful differences from the reference product.

Customizing the biosimilar development process
Once the clone is chosen, we custom design a process to effectively produce the biosimilar and promote its similarity to the reference product. This requires:

In-depth analyses of the cell-growth conditions
Harvest of the biosimilar from the cell
Further refinement of the biosimilar

Expanding into biosimilars to make biologics more accessible

Taj Pharmaceuticals is leading collaborative efforts here in the India and around the world to increase the availability and affordability of quality biologics through a new portfolio of biosimilars, just as we have done over the last several decades for IV medicines with our broad range of generic injectable offerings.

Applying extensive expertise and investment

Biological medicines present unusual production requirements — they are large, protein-based compounds grown in or derived from natural living cell lines and are packaged for administration by injection or infusion. Taj Pharmaceuticals is uniquely positioned to realize success in this challenging arena, with a proven track record in the United States in developing and delivering a reliable supply of IV drugs — many based on complex formulations and produced in unique ready-to-use bags and single-dose syringes. To these critical areas of expertise, we have added a growing team of international experts in the development of biologics and a new R&D center in Eysins, Switzerland, all backed by significant global investment.

Focusing on cancer and auto-immune diseases

Making affordable, high-quality health care available to patients coping with critical and chronic diseases is an integral part of Taj Pharma’s corporate purpose. To that end, our biosimilar portfolio will focus in two high-demand patient therapy areas: oncology, in which we already have one of the most comprehensive portfolios of traditional generic injectable medicines, and immunology. In both, we currently have multiple candidates in development.

7 biosimilars will be created in near years (2 products per year)

Rasburicase(Elitek Biosimilar)
Romiplostim (Nplate Biosimilar)
Teduglutide (Gattex Biosimilar)
Dulaglutide (Trulicity Biosimilar)
Reteplase(Rapilysin Biosimilar)
L-Asparaginase(Spectrila Biosimilar)
Certolizumab pegol (Cimzia Biosimilar)

2 biosimilars are ready for clinical trials and further marketing:

Teriparatide (biosimilar)
Anakinra (biosimilar)

We are always looking for the global partner who can invest in clinical trials and marketing.

Research and Development has 2 products:

Denosumab (biosimilar)
Adalimumab (biosimilar)
They are ready for clinical trials and further marketing.

ABOUT BIO-SIMILAR MANUFACTURING

Biosimilars are considered to be low-cost substitutions for pricy, large-molecule biologics. However, biosimilars must meet the same quality, safety, and efficacy as their reference biologic. Manufacturing biosimilars requires a more complicated procedure than that of manufacturing small molecule generics. Companies manufacturing biosimilars are focused on creating a chemical structure that is as close as possible to that of the reference product. Failure rates and operational costs pose a challenge for those companies involved in manufacturing biosimilars compared to those manufacturing small molecule generics.

Small molecule generics are created using the same active pharmaceutical ingredient (API) and, therefore, are chemically identical to that of the originator medicine. The manufacturing process for small molecules comprises only one-fifth of the total in-process tests required to meet Good Manufacturing Practice compared to that of biologic medicines (50 vs. 250 in-process tests). In fact, the manufacturing process for a large molecule is so complex, it cannot be duplicated by two different manufacturers, as the cells used in biologic medicines are unique to the company manufacturing each biologic.

Manufacturing a biologic consists of genetically modifying a cell, which becomes the basis for a cell line used for the production of the necessary protein for the biologic medicine. The protein is then separated from the cells and purified. Biosimilars are created from small alterations to the manufacturing process which creates a molecule that is not identical but closely resembles the reference product. While the differences in the biosimilar molecule might be slight, these changes in the manufacturing process of a biosimilar can affect the efficacy and safety of a biosimilar compared to the reference biologic. Over the past decade, the manufacturing process for proteins has become more standardized and the required technology has become increasingly accessible, leading to reductions in biosimilars production costs. As a result, a greater number of companies have begun manufacturing biosimilars, while reference brand manufacturers are setting their sights on bolstering pipelines and manufacturing biobetters to maintain market share for their soon-to-be-off-patent reference products.