Biosimilars, Indian Generic Companies and the Drug Regulators

The Business Standard reports that “Dr Reddy’s Laboratories, the country’s third-biggest drugmaker, will form a joint venture with one of the world’s biggest biotech companies to make biosimilars or generic versions of patented biotech drugs to take on Ranbaxy Laboratories, Reliance Life Sciences, among other Indian companies. Several drugs are expected to come off patent in this segment in the next five years.“

While the company is not willing to reveal any details at this point (as to who the partner is and what the terms of the deal are), this is indeed an interesting development. (Now why is one part of me thinking – is this another Ranbaxy-Daichi story in the making?) It is indeed inspiring to see Indian companies take on new challenges and partnering with more experiences partners is certainly a great way to bring the all-important “know-how” into India.

Biosimilars are different from generics in that they are much more complex molecules and have their basis primarily in biotechnology rather than chemistry. It is therefore not surprising that there’s hectic activity in countries such as the US and EU for the establishment of special standards for approval of Biosimilars; it is commonly believed that the abbreviated process used for approval of pharmaceutical generics is not appropriate for biosimilars as there are greater (health) risks associated with even the slightest modification in the manufacturing process of biosimilars.

The European Medicines Agency issued “Guidelines on Similar Biological Medicinal Products” way back in 2005. According to these guidelines, “Biological medicinal products are usually more difficult to characterise than chemically derived medicinal products. In addition, there is a spectrum of molecular complexity among the various products (recombinant DNA, blood or plasma-derived, immunologicals, gene and cell-therapy, etc.). Moreover, parameters such as the three-dimensional structure, the amount of acido-basic variants or post-translational modifications such as the glycosylation profile can be significantly altered by changes, which may initially be considered to be ‘minor’ in the manufacturing process. Thus, the safety/efficacy profile of these products is highly dependent on the robustness and the monitoring of quality aspects.”

According to the news reports I was able to uncover, even though the US is yet to finalize similar guidelines/laws, biosimilar drugs are “forging ahead” and as of October last year, “Biotech drugs account[ed] for around 10-15% of the current pharmaceutical market, and the sector [was] outperforming the market as a whole in terms of growth.”

As a number of patents in the Biologics sector are close to expiring in the near future. Is the Indian drug regulatory authority ready for this new, more challenging form of “generic” drugs?

Read more on Biologics here.
Related EU Directives of interest for researchers: Article 8 of Directive 2001/83; Article 10(4) of Directive 2001/83/EC and Section 4, Part II, Annex I to the said Directive [As amended by Directive 2003/63/EC, OJ L159 (p46) and Directive 2004/27/EC, OJ L136 (p34)]