The committee’s positive opinion brings the product one step closer to approval. The European Commission is slated to make a final decision in April.
“We are pleased with CHMP’s decision to recommend approval of Mylan and Biocon’s biosimilar insulin glargine. With approximately 60 million people living with diabetes in the European Region and prevalence on the rise, we have an important role to play to help increase access to high-quality, more affordable treatment options for patients,” Mylan president Rajiv Malik said in prepared remarks. “Mylan is a global leader in the development and manufacturing of complex products, and we are proud of our regulatory, clinical and scientific capabilities that have allowed us to reach this important milestone.”
“CHMP’s decision to recommend approval of Biocon and Mylan’s biosimilar insulin glargine brings us a step closer to offer high quality, affordable options for people with diabetes in the EU,” Biocon CEO Arun Chandavarkar added. “This is an outcome of our commitment to be a credible, global insulins player on the back of significant investments together with our partner Mylan in global scale manufacturing and R&D after having previously obtained approvals for our insulin glargine in Japan and key emerging markets.”
The companies are also seeking regulatory approval for Semglee in Australia, Canada and the U.S.
Mylan and Biocon have inked exclusive deals covering three insulin analogs, including Semglee. Mylan holds exclusive commercialization rights for insulin glargine in the U.S., Canada, Australia, New Zealand, the E.U. and European Free Trade Association countries, while Biocon has exclusive rights in Japan and some emerging markets.