Biosimilar is a biological product that resembles a reference product and is not difference from the already approved reference product. These are relatively cheaper than branded or approved products. Several biologics for oncology have already lost their patents, and some are in its period of expiry. As more products are expected to lose patents, biosimilar is expected to gain popularity. Leading generic players such as Mylan N.V., Teva Pharmaceutical Industries Ltd, Allergan Plc, Sandoz (a Novartis International AG’s division) are expected to capitalize on these patent expiries and may establish themselves as dominating players in oncology biosimilars market.
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There was about a decade gap in approval of first biosimilars in two key markets, Europe and the U.S. First biosimilar was approved in 2006 in Europe, however, in the U.S. first product was approved in 2015. But since approving the first biosimilar, the FDA has approved five products in 2017. Out of these five biosimilars, two were approved for oncology. First, oncology biosimilar Mvasi (bevacizumab-awwb) received approval in September 2017, and second one, Ogivri (trastuzumab) was approved in December 2017. In Europe, both of the products have been approved, and Mvasi received approval from European Commission in January 2018.
Moreover, there are number of biosimilar application pending in the U.S. and Europe. For Herceptin (trastuzumab) alone, there are around four application pending in the FDA. These four application are from Amgen and Allergan, Celltrion and Teva, Pfizer, and Samsung Bioepis. Recent approval of products, and potential approval in next few years is expected to boost the market growth over the forecast period.
On the basis of region, oncology biosimilars market by Coherent Market Insights is segmented into North America, Latin America, Europe, Asia Pacific, Middle East, and Africa. North America is expected to be the dominant market over the forecast period. U.S. FDA approved first biosimilar in 2015, almost a decade later than first biosimilar approval in Europe. However, since 2015, the number of approved products has increased rapidly. This is expected to be factor for growth of the market in North America. Moreover, currently there are number of products in pipeline, which may receive approval from the FDA over the forecast period. For instance, Pfizer Inc. — a U.S.-based company — has three biosimilar products (i.e. PF-05280014, PF-05280586 and PF-06439535) for oncology in Phase 3.