Biocon-Sandoz in global pact to develop and commercialize biosimilars

Biocon and Sandoz, a division of Swiss-pharmaceutical major Novartis, on Thursday said they have entered into a global partnership to develop, manufacture and commercialize multiple biosimilars in immunology and oncology for patients across the globe.

Under the terms of the agreement, both companies will share responsibility for end-to-end development, manufacturing and global regulatory approvals for a number of products and will have a cost and profit share arrangement globally.

“Worldwide commercialization responsibilities will be divided and each company’s strengths will be leveraged within specific geographies,” Biocon said in a statement.

Sandoz will lead commercialization in North America and the European Union, while Biocon will lead commercialization in the rest of the world.

Biocon’s spokesperson said both companies have identified certain biosimilars they will working upon, but declined to name them, saying the process was in a very nascent stage.

Biocon said it’s latest deal with Sandoz will not clash with its ongoing partnership with Mylan.

“Biocon’s collaboration with Sandoz addresses some of the biosimilar opportunities beyond the near term opportunities being addressed by Biocon’s existing successful global partnership with Mylan,” Biocon said.

Biocon has a successful ongoing tie-up with Mylan where Biocon will carry out development and manufacturing of biosimilars, while Mylan will take care of commercialization in regulated markets.

The partnership, entered into in 2009, covers six biosimilar programs that include Trastuzumab, Pegfilgrastim, Adalimumab, Bevacizumab, Etanercept and Filgrastim. Biocon-Mylan has received approval from US FDA for Trastuzumab, used in treatment of breast cancer caused by HER2 gene mutation.

“We are pleased to announce our collaboration with Sandoz for developing a set of next generation biosimilar products,” said Biocon Chairperson & Managing Director Kiran Mazumdar-Shaw.

“This synergistic partnership will enable us to scale up our capabilities for an ‘end to end’ play in the global biosimilars space,” Mazumdar-Shaw added.

“Today’s announcement bolsters our leadership position in biosimilars and positions us to continue to lead well into the future,” said Richard Francis, CEO, Sandoz.

“Biocon is a great complement to our proven biosimilar capabilities at Sandoz. Through this collaboration, we are reinforcing our long-term commitment to increase patient access to biologics,” Francis said.

“Together, we will be able to realize benefits at every stage of the value chain, from development, through manufacturing to commercialization,” said Carol Lynch, Global Head, Biopharmaceuticals, Sandoz.

An early mover in the biosimilars space, Biocon has successfully launched its insulin glargine in Japan, trastuzumab and bevacizumab biosimilars in India and rh-insulin, insulin glargine and biosimilar trastuzumab in a few emerging markets. It was the first Indian company to have a biosimilar approved by the US Food and Drug Administration.

Sandoz plans to launch five biosimilars targeting oncology and immunology by 2020. While Sandoz has US and Europe approval for Etanercept, used in treatment of autoimmune diseases, it’s cancer biosimilar Rituximab was approved in Europe.

The company is also targeting Adalimumab, Inflixmimab both used to treat autoimmune disorders and pegfilgrastim in Europe and US markets.

An analyst who didn’t want to be named, said Biocon may have got “better terms in profit share” in the Sandoz partnership compared to what it may get in the Mylan deal for lucrative markets such as US and Europe.

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