Oncology Biosimilars Market Overview and Share Forecasted With Major Key Players mgen , Allergan, Mylan N.V., Samsung Bioepis., Teva Pharmaceutical Industries , Pfizer

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.

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Oncology Biosimilars Market Taxonomy

By Cancer Type:

Lung Cancer
Colorectal cancer
Cervical Cancer
Breast Cancer
Kidney cancer
Stomach cancer
Brain Cancer
Others
By Product Type:

Monoclonal Antibody
Immunomodulators
Others

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.

Europe market is also expected to witness rapid growth over the forecast period. This is due to expected launch of major products in the market over the forecast period. Europe-based leading generic manufacturers such as Sandoz (a Novartis International AG’s division) and Mylan N.V. has shown interest in this field. Mylan N.V. has entered into a collaboration agreement with Biocon Limited to develop biosimilars in 2009. The duo got approval for their first biosimilar product in 2017 in U.S. and also, European Medicines Agency (EMA) has accepted resubmission for their Herceptin biosimilar in the same year. With increasing number of approved products, the oncology biosimilars market is expected to witness significant growth in the region over the forecast period.

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