Evolus gets CRL tied to its Botox biosimilar manufacturing design

In January, biotech Evolus warned investors that approval of its biosimilar candidate of Allergan’s signature drug Biotox might be delayed. It said FDA had raised questions about the contract manufacturer that will produce the drug. It turns out Evolus was only half right.

The Irvine, California-based biotech last week said the FDA had “fully validated” the Daewoong Pharmaceutical manufacturing facility in South Korea which was built for production of DWP-450. While the plant got an OK, Evolus’ manufacturing processes did not.

The agency issued a complete response letter to the company for its  botulinum neurotoxin candidate, citing concerns about the so-called Chemistry, Manufacturing, and Controls (“CMC”) processes Evolus had established for manufacturing it.

“Overall, we view these updates as positive, which together give us the line of sight necessary to build our commercial infrastructure,” Evolus CEO David Moatazedi said in statement.

He said the company will respond to the FDA’s questions within 90 days.

While it is bad news for Evolus, it is a positive development for Allergan which is facing a slew of biosimilars anxious to cut into Botox’s revenues, which were $2.3 billion in the U.S. last year and $3.2 billion worldwide.

Analysts have said that market share for Allergan’s top-selling Botox should be safe even after new competitors show up but a recent poll of 100 high-volume U.S. aesthetic physicians, suggested otherwise. The poll by analysts at Bernstein found that new entrants from Evolus, Revance  and Hugel could grab up to 34% of the market. Bernstein analyst Ronny Gal told clients a few months ago that it predicted Revance would capture the lion’s share at 18%, with the other two companies splitting a 13% share.

Since then, Mylan announced it had teamed up with Revance on a cheaper copy of Allergan’s top-selling drug.

Last week’s announcement also was good news for South Korea-based Daewoong, which built the new plant specifically to make the Allergan product. That effort seemed to be challenged in January when the FDA issued a Form 483 with 10 observations following the initial preinspection of the plant. But Evolus reported last week the the FDA has now issued a Establishment Inspection Report, or EIR, for Daewoong’s manufacturing facility that confirmed it had passed its most recent preapproval inspection.

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