The Emergence of the Era of Biosimilars

article written by: Mahesh Sundar
References: Included

The current Generics boom is expected to last uptil 2015 and one could question the growth opportunities for pharma companies beyond 2015. The next big opportunity for pharma, post the generics era seems to be with biosimilars. We may be nearing the end of the big blockbuster molecules from chemical synthesis and moving more & more towards biologics. Already about 6 (read) of the Top 15 drugs in the US are biologics and as we see more & more patent loss, more biologics would be entering this list and may probably stay up there.


The US FDA issued its first draft on biosimilars in 2012 and in March this year, the US state of Virginia became the first state to introduce laws to allow substitutions of biosimilars for prescribed biologic drugs(read). Europe is not far behind after the CHMP issued positive opinions about Imatinib (Novartis' Glivec) biosimilar from Teva.

Several cos. are already gearing up to develop biosimilars. Sandoz has an entire division focussed towards development of Biosimilars & is called Sandoz Biosimilars(read). Teva meanwhile announced a JV with Lonza for biosimilar deveopment (read). Pfizer meanwhile, recently mentioned that they have successfully developed biosimilar versions of Roche's Herceptin. Pfizer hopes to recover some lost revenue from Lipitor from its biosimilar products.

That said, Indian companies are not far behind. Ranbaxy already markets a version of Neupogen in the Indian markets and hopes to launch at least 3 biosimilars by 2015 (read). Dr. Reddy's GV Prasad who was recently appointed as the company's new head has plans to develop biogenerics.

Recently, Strides Arcolabs sold off its generic injectables business to Mylan and announed plans to invest a part of the proceeds of the sales of its injectables unit in a new plant to be built in Malaysia, exclusively to develop biologic products(read).

The period beyond 2015 may see companies slowly shifting from traditional chemically synthesised drug products to biologics & biosimilars. These may well prove to be the growth drivers post the current generics era. Infact we may even conclude that with the emergence of so many new biologics & mAbs, most new innovations may also be from the bio products.



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