Mylan and Biocon's Biosimilar Insulin Glargine Authorized in European Union and Australia

Mylan and Biocon have announced that their co-developed insulin glargine biosimilar, referencing Lantus, has been authorized for marketing by both the European Commission (EC), following a previous positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in January 2018, as well as by the Therapeutic Goods Administration of Australia.

The biosimilar insulin will be sold under the brand name Semglee in a 100 IU/mL 3mL prefilled pen presentation in both territories. The partnership says that it plans to launch the product in various markets in Europe in the second half of 2018, and in Australia “later this year.”

This is the first product from Mylan and Biocon’s joint portfolio to receive a marketing authorization in Europe, and Biocon’s CEO and joint managing director, Arun Chandavarkar, PhD, called the 2 approvals “important milestones” in its work with Mylan.

The partnership has also submitted the product for approval in the United States, though the drug will, if approved, follow the approval pathway for new drugs, not biosimilars; in the United States, insulins are currently regulated as drugs and not as biologics, and follow-on product sponsors must therefore submit New Drug Applications (NDAs), rather than Biologics License Applications, for these drugs.

In addition to being subject to a different approval path in the United States, Semglee also faces unique legal obstacles along the road to reach the US market; in October 2017, Sanofi, maker of the reference Lantus, sued Mylan in a New Jersey district court, saying that Mylan has infringed on 18 patents for the reference drug in developing Semglee. According to Sanofi, the Mylan NDA for Semglee included a challenge to all of Sanofi’s patents listed for Lantus in the FDA’s orange book. Then, in December 2017, Mylan announced that the United States Patent Trial and Appeal Board had instituted inter partes review proceedings against all claims of 2 patents covering Sanofi’s Lantus.

US regulatory challenges linger for the drug, as well. In February, Biocon received a Form 483 from the FDA, noting 6 observations, after a pre-approval inspection of its insulin manufacturing facility in Malaysia revealed conditions that may have constituted violations of the Food Drug and Cosmetic Act.