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The FDA has approved Celltrion and Teva’s Herzuma (trastuzumab-pkrb), a biosimilar trastuzumab referencing Herceptin, for the treatment of HER2-positive breast cancer.
The Center for Biosimilars® recaps the top news for the week of December 10, 2018.
In its annual preview of the landscape for pharmaceuticals, Vantage predicted that 2019 will be a year of shakeups for the industry, with biosimilars potentially playing a substantial role.
Pfizer disclosed that it would increase the price of 41 drugs; 37 drugs will see price increases of 5%, 1 drug by 9%, and 3 drugs by 3% on January 15, 2019. The announcement was met with pushback from politicians who have been vocal about drug pricing concerns.
Chinese biologics developer Innovent has announced that its proposed bevacizumab candidate, IBI305, has met its primary end points in 2 randomized, head-to-head clinical trials that compared the biosimilar to the brand-name bevacizumab (Avastin).
 
Recently, plaintiff Genentech and defendant Pfizer filed a collective stipulation and proposed order of dismissal of a patent infringement lawsuit over Genentech’s reference trastuzumab product, Herceptin.
 
Amgen and Entera Bio have announced that they have entered into a research collaboration and license agreement to develop orally administered formulations of biologic drugs.
In October, the FDA granted approval for a pre-filled syringe formulation of the reference product. Additionally, Novartis is looking to expand omalizumab’s indications, as it recently earned FDA’s breakthrough therapy designation in August 2018 as a treatment for food allergies. 
Coherus Biosciences, which recently gained its first biosimilar approval for Udenyca, a pegfilgrastim biosimilar referencing Neulasta, has announced that it has signed a 340B prime vendor program contract with Apexus LLC.
The complaint includes a screenshot of Xanthe Lam’s Genentech-issued computer, which shows a folder titled “JHL” that contained subfolders, 4 of which were named for Genentech medicines for which JHL was in the process of developing a biosimilar.

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