Baxalta was developed jointly with other companies, adalimumab biosimilar with Momenta Pharmaceuticals and etanercept biosimilar with Coherus BioSciences.
Recently, Merck KGaA was also reported to be reevaluating its biosimilars business. It will be no surprise if we see further consolidation in this space in the years to come. The biosimilars development pipelines are crowded and the area is highly competitive. The market may be able to sustain only a limited number of players ultimately. So only those who have the long term focus will remain. Given the nature of biosimilars business, partnerships will continue to play an important role in this domain.
Spurring innovation
Originators have responded to the impending biosimilars challenge with a combination of strategies that prominently include extension of patents, patent litigation, dropping prices, developing newer formulations or obtaining additional indications for existing biologics, developing their own biosimilar assets, or developing bio-better or next generation products. Most importantly, the competition from biosimilars is an important driver for innovation, paving the way for newer therapeutic options and thus influencing patient outcomes positively.
Biosimilars development in Asia
Asian manufacturers, especially from South Korea, continue to be significant players in the current biosimilars landscape, with rich product pipelines as well as a number of approved products in both the EU & US.
South Korea is reported to have a goal of controlling 22 % of the global biosimilars market by 2020. This goal is supported by the Korean government by way of providing capital as well as regulatory assistance to the domestic bioplharmaceutical companies.
A number of Asian
companies are now looking at entering the global markets, and seem to be adopting global development strategies right from the outset instead of their earlier approach of developing products for local / regional markets first followed by the Western markets.
Indian Central Drugs Standard Control Organization( CDSCO) guidelines for biosimilars were revised recently.
Note: References available on request.
Dr Charu Manaktala is the Senior Medical Director and Head of Asia Pacific Biosimilars Centre of Excellence, Strategic Drug Development, QuintilesIMS Asia.
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