Biocon and Mylan claim lead as EMA starts review of Herceptin biosimilar

Biocon and partner Mylan have moved one step closer to launching a Herceptin biosimilar in Europe--and they claim they've beaten their rivals to the punch.

The European Medicines Agency (EMA) accepted their marketing application for the biosimilar version of Roche's blockbuster breast cancer drug, kicking off the review process. The two companies believe they're the first to reach this regulatory milestone, putting them in front of competitors such as Celltrion, Pfizer's Hospira subsidiary and Samsung Bioepis. 

Mylan president Rajiv Malik said Europe is a key market for biosimilars "as governments across the region strive to reduce healthcare costs." If the launch of Remicade biosimilars is any indication, the market is ripe. Merck & Co., which markets the branded anti-inflammatory drug in the region, has reported unexpectedly severe sales declines.

Roche's EU patents on Herceptin (trastuzumab) expired in 2014, but it remains the Swiss group's third-biggest drug with sales of CHF 6.5 billion ($6.6 billion) last year, CHF 2 billion of that total coming from the European market. Last month Roche's head of pharma, Dan O'Day, said he did not expect biosimilars of the drug to reach western markets until late 2017.

Phase III data on Biocon and Mylan's biosimilar--code-named MYL-1401O--was presented earlier this year at the American Society of Clinical Oncology (ASCO) meeting and showed it achieved the same overall response level as Herceptin after 24 weeks of therapy. 

Mylan and Bangalore-based Biocon first launched their biosimilar trastuzumab in India in 2013, prompting a legal dispute with Roche over labels claims. The two partners followed India up with launches in other emerging markets. 

Their partnership has not yet resulted in any marketed drugs in Europe, although the duo has a biosimilar of Amgen's Neulasta (pegfilgrastim) under review by the EMA. They have also said they intend to submit biosimilar Neulasta and Herceptin in the U.S. in the coming months. 

Meanwhile, Celltrion also has a Herceptin biosimilar on the market in South Korea under the Herzuma brand name but has not yet filed for EU approval of the drug. Other biosimilar developers with aspirations to take on the brand are still at the Phase III testing stage.

- here's the release

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