Ways2Capital Reviews : Competition For Herceptin Biosimilar Heats Up In Europe

The competition for Herceptin biosimilar is heating up in Europe after The European Medicines Agency (EMA) has recommended approval to Pfizer’s Trastuzumab biosimilar. Biocon and its partner Mylan have also submitted their copy of Herceptin biosimilar in Europe and have received approval in the US.

Yesterday, EMA recommended approval to Pfizer’s Trastuzumab biosimilar branded as Trazimera. The committee for medicinal products for human use (CHMP) has recommended marketing authorization to Trazimera to European Commission (EC). The EC will review the CHMP’s positive opinion before deciding whether to grant Pfizer marketing authorization. Trazimera is indicted in the treatment of types of cancers.

Biocon/Mylan have submitted their copy of Trastuzumab and Pegfilgrastim biosimilars for Marketing Authorisation in Europe while on Tuesday they received approval to Pegfilgrastim biosimilar in the US but a CRL on Insulin Glargine.

The competition in Herceptin was anticipated and this should not impact Biocon's long-term plans. With the US approval to Trastuzumab and Pegfilgrastim, the earnings are expected to be strong going ahead. Approval in Europe for Trastuzumab and Pegfilgrastim would further sweeten the earnings for Biocon.
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About Bhoomi Desai