Biosimilars

Another player drops out of the biosimilars business as shakeout continues

The shakeout on the hotly competitive biosimilars front is continuing.

Just a few weeks after Merck KGaA made its exit from the field after striking a deal to sell off its portfolio of biologic knockoffs to Fresenius for €170 million up front, India’s Cipla says it plans to execute a retreat from biosimilars.

Umang Vohra

CEO Umang Vohra says he’s looking for partners to pick up on the biosimilar programs it has underway, saying the field is getting too competitive to continue to pump money into R&D.

“We may play a smaller portion of the overall development and let a partner take on a larger portion,” he said, according to a report from Reuters. “We believe that the profile of the biosimilars market today has become fairly competitive.”

Three years ago, as the biosimilars business was just getting off the ground in a big way, Cipla chairman Yusuf Hamied said he dreamed of a day when the company could make biologics available around the world at a fraction of the branded cost — much the way oral generics have sliced and diced the price of off-patent drugs.

In the meantime, Pfizer, Merck, Novartis, Samsung and others have been elbowing into the biosimilars game, attracted by the low development risk and the prospect of competing against drugs like Humira, which earned $16 billion last year as AbbVie continues to up the price.

Cipla’s two programs for Avastin (bevacizumab) and Herceptin (trastuzumab) mirror similar work underway among some ambitious rivals.

Just yesterday Pfizer won the support of an expert FDA panel to start marketing a copycat of a blockbuster anemia drug Amgen sells as Epogen and J&J markets as Procrit. And FDA reviewers had no trouble endorsing the effort, saying the biosimilar was a close match to the original.

As these biosimilars accumulate in the market, other marginal players weighing the cost of entry and the size of the competition are also likely to follow Cipla to the sidelines.


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RAPS Regulatory Convergence 2017