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Novartis doubles down on biosimilars with Biocon alliance

The companies will develop multiple immunology and oncology biosimilars

Novartis

Already a big player in the emerging biosimilars market, Novartis has struck a deal with India’s Biocon in a bid to extend its position.

Under the terms of the new deal the two companies will develop and bring to market “multiple biosimilars in immunology and oncology” that will “address the next wave of biosimilar opportunities globally”.

The deal with Novartis' subsidiary Sandoz comes after Biocon resolved problems at its manufacturing facility that forced it to withdraw EU filings for biosimilar versions of Roche's breast cancer drug Herceptin (trastuzumab) and Amgen's long-acting white cell booster Neulasta (pegfilgrastim) last August at the request of the EMA. It solved those issues and picked up EMA approval for the Mylan-partnered biosimilars in December.

The companies will share responsibility for development, manufacturing and regulatory approvals for the products under a cost- and profit-share arrangement, with Sandoz leading commercial activities in North America and Europe and Biocon taking the lead elsewhere.

Sandoz has already chalked up some big biosimilar approvals, and just this week the FDA started to review its biosimilar of AbbVie’s immunology blockbuster Humira (adalimumab), which has also been filed in the EU.

In the last couple of years it has picked up approvals for Rixathon - a biosimilar of Roche’s cancer and arthritis drug MabThera (rituximab) - as well as its Erelzi version of Amgen’s TNF inhibitor Enbrel (etanercept). Previous launches have included its Glatopa version of Teva’s multiple sclerosis drug Copaxone (glatiramer acetate) and Zarxio, a variant of Amgen’s Neupogen (filgrastim).

Biocon meanwhile has launched an insulin glargine biosimilar in Japan to rival Sanofi’s Lantus brand, trastuzumab and Roche’s Avastin (bevacizumab) biosimilars in India and recombinant human insulin, insulin glargine and trastuzumab drugs in some emerging markets.

The deal “bolsters our leadership position in biosimilars and positions us to continue to lead well into the future”, said Richard Francis, Sandoz’ chief executive.

“Through this collaboration, we are reinforcing our long-term commitment to increase patient access to biologics,” he added.

With a slew of big-selling biologic blockbusters losing patent protection, Sandoz sees biosimilars as an important way to improve profitability and growth given the pricing and competitive pressure on conventional small-molecule generic drugs in recent years.

Article by
Phil Taylor

19th January 2018

From: Research

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