Biosimilars

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.

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.