Mylan announces Momenta collaboration to develop six biosimilars
pharmafile | January 8, 2016 | News story | Manufacturing and Production, Sales and Marketing | Heather Bresch, Momenta, Mylan, biosimilars
Mylan has entered an exclusive global collaboration agreement with Momenta Pharmaceuticals, to develop, manufacture and commercialise six of Momenta’s biosimilar candidates.
The replica drugs will include cheaper versions of Bristol-Myers Squibb’s Orencia (abatacept), and its Humira (adalimumab) copycat, M923.
Mylan will make an up-front cash payment of $45 million and up to $200 million in contingent milestone-related payments to Massachusetts-based Momenta, with each company equally sharing in the costs and profits. The companies will be jointly responsible for product development, and Mylan will lead worldwide commercialisation efforts.
Mylan chief executive Heather Bresch said the new partnership would complement its long-running biologics and insulin analog agreement with Biocon, and would position Mylan as a ‘definitive world leader in biosimilars.’ The company currently has 15 biosimilar and insulin analog generic products in development.
Bresch comments: “Mylan’s long-stated strategy has been to strategically invest in the long-term drivers of our future growth, both through our strong internal focus on R&D and through external collaboration with industry-leading partners.
“Biosimilars have long been one of these areas of important future growth, both for our company and our industry, given the rapidly growing market for biologic products, the undeniable patient need for more affordable versions of these life-saving medicines, and the attractive competitive landscape for the companies that are able to successfully bring these complex products at scale to the global market.
“This exciting collaboration with Momenta is focused on the next wave of biosimilar products and represents an important next step for Mylan, leveraging Momenta’s unique technology capabilities and Mylan’s strong science, biosimilar-development experience, operational excellence and expansive global commercial footprint.
Craig Wheeler, president and chief executive of Momenta Pharmaceuticals, says: “We are thrilled to welcome Mylan as our new collaboration partner for biosimilars. Our two companies have a common focus on building an industry-leading biosimilar portfolio that offers safe, effective and affordable products to the patients that need them.
“By combining Momenta’s proven capabilities in complex-product development and Mylan’s world-class global R&D, supply chain and commercial infrastructure, we are well positioned to become a strong competitor in this developing field. Our joint vision is to bring high quality, cost-effective biosimilar products to markets worldwide, and we believe our success will deliver a strong return to our companies’ stakeholders.”
Mylan president, Rajiv Malik, adds, “Mylan has been fully engaged in the development of biosimilars with our partner Biocon for the last six years. During that time, Mylan has cultivated strong experience and expertise in the development of biosimilar products, and is executing on our programs with the scientific and analytical rigor required to fulfill health-authority expectations.
“Based upon our proactive and informative interactions with global health authorities on our nine active programs, we are extremely optimistic about the strength of our current development programs with Biocon, and we look forward to deploying our expertise in our collaboration with Momenta.”
Mylan’s partnership with Biocon includes six biosimilar programs: trastuzumab, pegfilgrastim, adalimumab, bevacizumab, etanercept and filgrastim; and three insulin analogs: glargine, lispro and aspart.
Five of these biosimilar programs have successfully completed Phase I clinical trials, and four of the programs are in active Phase III testing. Mylan and Biocon plan to submit three biosimilar applications and one insulin application in the US and Europe in 2016.
Joel Levy
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