May 14, 2021
Terry Mahn Quoted in Biosimilar Development Article, "Surveying The Current Legal Landscape For Biosimilars"
Terry Mahn (Principal) was quoted in Biosimilar Development article, "Surveying The Current Legal Landscape For Biosimilars" on May 3, 2017.
Were there any noteworthy developments during oral arguments in the Amgen v. Sandoz Supreme Court hearing?
Terry Mahn, Fish & Richardson: The bench was very active during oral arguments. Although not fully briefed, the justices were interested in the interplay between the BPCIA and state laws. Aside from the text of the statute, the justices also expressed interest in understanding the role of the FDA in the process and whether a reference product sponsor could have a good faith basis to sue if it did not have access to the abbreviated biologics license application (aBLA).
In the biosimilar litigation landscape, we've already seen one settlement take place between Genentech and Mylan (March 2017). Is there anything biosimilar developers should take note of from this settlement, and should we expect to see many more instances of this in the future?
Mahn: Settlements in the biosimilar space will carry the same risks for consumers (e.g., higher prices due to market collusion) that they carry in the Hatch-Waxman (H-W) space, only there will be fewer co-conspirators (interchangeable biosimilars) involved.
Acknowledgement: Terry Mahn would like to thank his colleague Tasha Francis, Ph.D., for her contributions to his responses.
To view the full article, please click here.
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