As we previously reported, on October 6, 2017, Amgen and Genentech filed separate lawsuits regarding Amgen’s bevacizumab biosimilar (MVASI®), with Amgen filing for declaratory judgment in C.D….
As we previously reported, on October 6, 2017, Amgen and Genentech filed separate lawsuits regarding Amgen’s bevacizumab biosimilar (MVASI®), with Amgen filing for declaratory judgment in C.D….
Sandoz, a division of Novartis, announced on Tuesday that the FDA has accepted for review its BLA under the 351(k) pathway for a biosimilar candidate to AbbVie’s Humira (adalimumab). According…
As we previously reported, Genentech has filed two pending cases (Case Nos. 1:17-cv-01407 and 1:17-cv-01471) in the District of Delaware related to Amgen’s proposed Mvasi (bevacizumab-awwb), a…
It has been reported that manufacturer AbbVie will increase the price of Humira® (adalimumab) by 9.7% in 2018. According to Wells Fargo analyst David Maris, this price increase could add…
Hetero announced this week the launch in India of its adalimumab biosimilar, marketed under the brand name Mabura. Mabura is a biosimilar of AbbVie’s Humira and is indicated for the…
As we reported previously, Amgen is seeking en banc review of the Federal Circuit panel decision vacating a permanent injunction that would have otherwise prohibited the sale of Sanofi and…
Here are our picks for the top-5 biggest deals in the world of biosimilars in 2017: 5. Companies developing biosimilar products continue to establish partnerships to market and distribute…
Here are our picks for the top-five most significant legal developments regarding biosimilars in 2017: 5. In January 2017, the FDA released a draft guidance on biosimilar…
Here are our picks for the top-five most significant U.S. market developments in the world of biosimilars in 2017: 1. Compared to three approvals in 2016, the FDA approved five…
As we previously reported, last month a Federal Circuit panel affirmed the district court’s judgment that Apotex’s pegfilgrastim and filgrastim biosimilar candidates do not infringe Amgen’s…