HONG KONG – Less than two months after picking up a big win with the FDA approval for Mylan NV-partnered Herceptin biosimilar Ogivri (trastuzumab-dkst), India's Biocon Ltd. inked a deal with another leader in biosimilar development, Sandoz Inc., a division of Novartis AG, to develop, manufacture and commercialize multiple products in the areas of immunology and oncology.
Besides addressing the next wave of global biosimilar opportunities, a key goal of the partnership is to provide the foundation for both parties to expand their portfolios.
Under the terms, the companies will share the responsibility for end-to-end development, manufacturing and obtaining global regulatory approvals for a number of products.
"This collaboration aims to help patients worldwide gain access to a range of high-quality, affordable immunology and oncology biologics," Michelle Bauman, head of product communications for Sandoz, told BioWorld Asia. "The early stage biosimilar assets that are part of this agreement complement our existing portfolio in immunology and oncology."
Worldwide commercialization responsibilities will be divided and each company's strengths will be leveraged for specific markets. Sandoz will take the lead in commercialization for North America and the EU region, while Biocon will take charge of commercialization for the other markets around the world.
Both companies involved will operate under a global cost and profit-share arrangement.
Kiran Mazumdar-Shaw, chairperson and managing director for Biocon, said she believes the Sandoz partnership will help the Indian biosimilar leader scale up its capabilities for an "end-to-end" play in the global biosimilars space.
Bengaluru-based Biocon is entering the latest partnership fresh from some recent triumphs generated by its earlier work with Mylan. In addition to the Ogivri approval, Biocon received a positive opinion this month from the EMA's Committee for Medicinal Products for Human Use (CHMP) recommending the approval of Semglee, an insulin glargine developed in collaboration with Mylan. (See BioWorld, Dec. 18, 2017.)
The CHMP's positive opinion will be considered by the European Commission, which is expected to provide a decision on the approval of Semglee in April.
Arun Chandavarkar, the CEO and joint managing director for Biocon, cited the firm's significant investments, together with Mylan, in global scale manufacturing and R&D.
As an early mover in the biosimilars space, Biocon has already successfully launched its trastuzumab and bevacizumab biosimilars in India, insulin glargine in Japan, and rh-insulin, insulin glargine and biosimilar trastuzumab in a few emerging markets. Last month, Brazil regulators cleared the trastuzumab biosimilar.
The recent FDA approval was particularly significant as it marked the first trastuzumab biosimilar to be given the green light in the U.S. That progress should expedite the approval in other markets, where the biosimilar is under review, including Australia, Canada and the EU.
Ogivri's reference drug, Herceptin (Roche Holding AG), had U.S. sales of more than $2 billion for the 12 months ending Sept. 30, according to health care analytics company IQVIA.
India spurring biosimilar growth
"Many Indian generic companies are investing in and developing their capacity to manufacture biosimilars," Malini Aisola, a member of the All India Action Drug Network, told BioWorld Asia. "This underscores a trend towards biosimilars in the South Asian country."
According to the Generics and Biosimilars Initiative Journal, India's first biosimilar, a hepatitis B vaccine, was approved and marketed in 2000. That puts the country about 15 years ahead of the U.S. in terms of regulatory acceptance of similar biologics.
But Aisola noted that there is a need for stronger support and regulation from the authorities to make biosimilars accessible.
"The priority of course should first be access to Indian people. We are supportive of developing local capabilities to manufacture biosimilars to meet the health care needs which are currently out of reach of the majority of Indians," said Aisola.
"The potential of Indian biosimilars, with the appropriate regulation, is to bring to market lower-cost medicines," she added. "This is unlike big pharma companies that market biosimilars without the necessary and adequate price reductions needed to make them affordable."
Sandoz acknowledges that aspect in the increasing adoption of biosimilars, but is determined to try different approaches to introduce the products to more markets.
"As we do in other countries, pricing of biosimilars will continue to vary considerably by product, market and channel, and depending on the level of competition," said Sandoz's Bauman. "But we know price is only one aspect driving uptake, and as we enter new geographies, we'll continue to focus on building confidence through education."