Dive Brief:
- Mundipharma International will expand its commercialization agreement with the Hungarian subsidiary of Celltrion Inc. to distribute a third biosimilar for the South Korean developer.
- Under the broadened pact, Mundipharma will distribute Celltrion's biosimilar of Roche's breast cancer drug Herceptin in seven European countries, including the U.K., Germany and Italy.
- Celltrion's Herzuma, as the copycat version is branded, was approved in the EU in February for the treatment of patients with early breast cancer, metastatic breast cancer or metastatic gastric cancer whose tumors have either HER2 overexpression or HER2 gene amplification.
Dive Insight:
Approval of Herzuma makes it the second biosimilar of Roche's blockbuster cancer drug Herceptin (trastuzumab) to be OK'd in Europe. Celltrion's South Korean rival Samsung Bioepis Co. Ltd. also gained approval for its version of the cancer drug, called Ontruzant, a month earlier for the same indications.
In the U.S., generics makers Mylan N.V. and Biocon Ltd. secured approval for their version of Herceptin late last year.
Copycats versions of Roche's other blockbuster cancer drugs Avastin (bevacizumab) and Rituxan (rituximab) have already found a foothold in Europe and are starting to emerge in the U.S. as well — showing the increasing threat to three of the Swiss pharma's largest franchises. Herceptin alone brought in $7.4 billion for Roche worldwide last year.
For its part, Mundipharma — a grouping of associated private companies — is capitalizing on Celltrion's strong presence as a biosimilar drugmaker. The pair already have two other marketing partnerships in place that tap Mundipharma's network across Europe. A year ago, the pair hooked up on Celltrion's Truxima, a biosimilar of Rituxan/MabThera. Prior to that agreement, Celltrion tapped Mundipharma to market its copy of Remicade (infliximab).
"They have a proven track record of launching biosimilars in Europe, working effectively across multiple healthcare systems and demonstrating local in-market expertise," said Celltrion CEO Man Hoon Kim in a statement.
Biosimilars have been on the market for some time in Europe, but have yet to have a real impact commercially in the U.S. Currently there are nine biosimilars approved by the Food and Drug Administration, but only three have reached the market due to patent litigation and settlement deals between pharmaceutical companies. Should biosimilars take hold in the U.S., reports suggest they could save the U.S. healthcare system substantial sums over the widely used, but costly, branded biologics.