Revance and Mylan Move Forward With Development Plan for BOTOX Biosimilar

Goodwin
Contact

GoodwinWe have previously posted on the partnership between Revance and Mylan on a biosimilar to BOTOX®. Following favorable feedback from FDA and recent results from additional characterization and analysis studies performed by Revance, it was announced this week that Mylan plans to move forward with a development plan, under a 351(k) pathway, for this neuromodulator biosimilar. The press release also reported that “[w]ith Mylan’s decision to move forward with the development program announced today, a payment of $30 million is now payable to Revance by Mylan. Furthermore, the collaboration and license agreement also provides for an additional $70 million in milestone payments, contingent upon the achievement of further clinical and regulatory milestones. Additionally, per the agreement, Revance is eligible to receive sales target milestone payments and royalties in all relevant markets.”

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© Goodwin | Attorney Advertising

Written by:

Goodwin
Contact
more
less

Goodwin on:

Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Custom Email Digest
- hide
- hide

This website uses cookies to improve user experience, track anonymous site usage, store authorization tokens and permit sharing on social media networks. By continuing to browse this website you accept the use of cookies. Click here to read more about how we use cookies.