Samsung Bioepis first to secure EMA backing for Herceptin biosimilar

Dive Brief:

  • Korean drugmaker Samsung Bioepis Co. Ltd said Friday a key committee of the European Medicines Agency had recommended approval for its biosimilar version of Roche AG’s breast cancer drug Herceptin.
  • The European Commission will now decide whether to grant marketing authorization to the copycat biologic, which would be sold as Ontruzant by Samsung Bioepis’ partner Merck & Co. The regulator usually acts within two months of an EMA recommendation.
  • Securing EMA backing positions Samsung Bioepis to be the first company to market a Herceptin biosimilar in Europe. A handful of other companies are also moving forward with rival copies in an effort to muscle in on the biologic’s lucrative market.

Dive Insight:

EMA endorsement of Ontruzant (trastuzumab) caps a good quarter for the Korean drugmaker, which until recently only focused on biosimilar drug development.

Last month, Samsung Bioepis secured full approval of its copy of AbbVie Inc.’s TNF inhibitor Humira (adalimumab). The company had previously won regulatory OK in Europe for Amgen’s Enbrel (etanercept) and of Remicade (infliximab), which is marketed by Merck & Co. in the region but sold by Johnson & Johnson in the U.S.

Taken together and Samsung Bioepis has assembled an impressive portfolio of copies to the industry’s top-selling drugs for inflammatory conditions. Ontruzant, if authorized by the EC, would be the company’s first cancer biosimilar and mark the arrival of competition to Herceptin (trastuzumab).

In 2016, Herceptin earned CHF 2.06 billion ($2.03 billion), up 2% from the year prior. Anticipating biosimilar entry, Roche has been trying to drive higher volume by converting patients to a subcutaneous formulation. Ontruzant, if authorized, would be available as a powder for concentrate to infuse via solution.

Roche also hopes to convince physicians to pair Herceptin with its newer follow-on breast cancer med Perjeta (pertuzumab). A study known as APHINITY showed combining the two drugs following surgery lowered the risk of invasive disease recurrence or death by 19%. But some analysts and physicians had expected to see a greater benefit, dampening some of the enthusiasm for packaging two expensive biologics together.

In the U.S., where Roche earned a similar $2.48 billion from Herceptin sales last year, Samsung recently requested three inter partes reviews for patents held by Roche subsidiary Genentech on Herceptin. Legal defenses have largely hung up entry of biosimilars in the U.S., which lags behind Europe in adoption.

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