This morning AbbVie announced that it has entered into patent license agreements with Mylan over its proposed biosimilar of Humira® (adalimumab). AbbVie states that it has agreed to “grant Mylan a non-exclusive license on specified dates to AbbVie’s intellectual property relating to HUMIRA in the United States and in various…
Today, XBrane Biopharma and STADA Arzneimittel announced that they have entered into a co-development agreement for Xlucane, a proposed biosimilar of Lucentis® (ranibizumab), in which the companies will equally contribute and share in profits from commercialization in a 50/50 split. According to the press release, Xbrane will be responsible for…
Earlier this week, JHL Biotech announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has provided it with positive scientific advice regarding JHL1101, its proposed biosimilar of MabThera® (rituximab). According to the press release, “the EMA confirmed that it agrees with JHL’s…
In a series of tweets on July 8, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, M.D., announced that the FDA “will soon unveil a comprehensive Biosimilars Action Plan (BAP) that will include policies and actions to improve the efficiency of FDA’s review of biosimilar marketing applications and increase…
The FDA recently announced the availability of a final guidance for industry titled “Assessing User Fees Under the Biosimilar User Fee Amendments of 2017.” This guidance concerns the implementation of BsUFA II, which as we previously reported, extends FDA’s authority to collect user fees from fiscal year (FY) 2018 to…
Today, we’re catching up with news from around the industry. Amgen recently announced top-line results from a Phase 3 study evaluating its infliximab biosimilar candidate, ABP 710. According to the announcement, the study, a randomized, double-blind trial of 558 patients over 22 weeks, demonstrated the non-inferiority of ABP 710 to…
United States Senators Chuck Grassley (R-Iowa) and Amy Klobuchar (D-Minn.) recently sent a letter to Federal Trade Commission (FTC) Chairman Joseph Simons urging the “FTC to examine global patent settlements relating to biosimilars to ensure they are not in violation of antitrust laws.” According to the Senators, “biologics constitute a…
Earlier this month, ACON Investments, a Washington, DC-based international private equity investment firm, announced that affiliates of ACON Latin America Opportunities Fund IV, L.P., in partnership with Humus Capital Partners (HCP), a middle-market private equity firm based in Buenos Aires, have acquired a majority equity interest in Biosidus S.A. and Biosidus…
Earlier this month, Oncobiologics, Inc. announced that it entered into a Master Service Agreement with Sonnet BioTherapeutics, Inc. that engages Oncobiologics to provide Contract Development and Manufacturing (CDMO) services for up to four drug product candidates over the next three years. According to the press release, this is the first CDMO agreement…
As we previously reported, in September 2017 FDA issued draft guidance entitled Statistical Approaches to Evaluate Analytical Similarity that “describes the type[s] of information a sponsor of a proposed biosimilar product should obtain” to support a showing of analytical similarity to a licensed reference product biologic. Today, FDA withdrew this draft guidance….