- Mylan has removed a legal hurdle blocking the potential U.S. launch of its biosimilar to Roche's blockbuster cancer drug Herceptin (trastuzumab), announcing Monday it had reached a settlement agreement with the Swiss pharma.
- Under the agreement, Roche granted Mylan a license for marketing its trastuzumab biosimilar in all countries except Japan, Brazil and Mexico. As a result, Mylan has now withdrawn two legal challenges against patents held by Roche subsidiary Genentech on Herceptin.
- Mylan and its partner Biocon Ltd. have already successfully submitted an application for approval of the biosimilar and the Food and Drug Administration has set a target decision date of Sept. 3. If approved, Mylan and Biocon's copy would be the first Herceptin biosimilar approved in the U.S.
Mylan has been pushing forward with its pipeline of biosimilar candidates, positioning itself for two potential approvals this year.
Through a partnership with Biocon, Mylan has submitted biosimilars of both Herceptin and Amgen's Neulasta (pegfilgrastim) for FDA approval. While other biosimilar makers have moved Neulasta biosimilars into regulatory review already, Mylan believes it will be ahead of competitors with Herceptin.
Mylan already markets trastuzumab copies in 14 emerging markets, but the real value for biosimilars will be in developed markets such as the U.S. and Europe. Sales of the cancer drug in those regions totaled nearly $4.5 billion in 2016.
By coming to an agreement with Roche, Mylan eliminates the risk of a legal challenge from Roche to a launch of the biosimilar (if approved) while also putting a stop to patent litigation expenses. The license effective date is confidential, but it would stand to reason Roche extended its exclusivity window for Herceptin for some time in exchange for granting a license.
Mylan has a broad portfolio of biosimilar candidates, both under its partnership with Biocon and through an agreement with Momenta Pharmaceuticals to develop and commercialize six of Momenta's biosimilar candidates. A copy of Bristol-Myers Squibb's Orencia (abatacept) appears furthest along in development under that collaboration, with an expected 2020 launch.