As we have previously reported, Donald Trump’s election to the presidency and the maintenance of majorities by the Republican Party in both the U.S. Senate and House of Representatives have led to questions about the fate of the BPCIA, which passed as part of the Affordable Care Act (“ACA”), colloquially known as…
Today, Boehringer Ingelheim announced that results from a Phase I study demonstrate its bevacizumab biosimilar candidate, “BI 695502,” is bioequivalent to Avastin®. According to the announcement, BI 695502 met all the pre-defined primary and secondary endpoints in Boehringer Ingelheim’s “INVICTAN®-1″ study, with no clinically relevant differences in safety or immunogenicity found between the study’s BI…
As we previously reported, Amgen and Allergan are currently collaborating on four oncology biosimilars, including an Avastin® (bevacizumab) biosimilar, ABP 215. Yesterday, the companies announced the submission of a Biologics License Application (BLA) to FDA for ABP 215. According to the announcement, Amgen and Allergan believe theirs is the first BLA for a bevacizumab biosimilar…
According to a Mabion press release, Mylan recently reached a deal with Mabion, a Polish biotech firm, for the exclusive right to commercialize Mabion’s rituximab biosimilar candidate in EU countries and non-EU Balkan states. The deal included an upfront payment of $10 million and additional milestone payments and royalties. Rituximab is…
On this blog, we have been following two Celltrion biosimilars: CT-P10 (rituximab) and CT-P13 (infliximab, the subject of the Janssen v. Celltrion litigation). According to a Celltrion press release, new data released today at the 2016 American College of Rheumatology (ACR) Annual Meeting show that the efficacy and safety profile…
This morning, Eagle Pharmaceuticals announced that it has entered into an agreement to acquire Arsia Therapeutics. According to Arsia’s website, Arsia’s technology enables the production of high-concentration, low-viscosity biologics that can be delivered to patients by subcutaneous injection, autoinjector pen, or patch pump. Eagle’s press release states that the acquisition…
The Committee for Medicinal Products for Human Use, (“CHMP”), the committee at the European Medicines Agency (“EMA”) that is responsible for preparing opinions on questions concerning medicines for human use met earlier this week and recommended approval of nine medicines to the EMA. Of the nine medicines recommended for approval,…
If you plan to attend next week’s 2016 BIO Intellectual Property Counsels Committee Fall Conference, please keep an eye out for members of the Big Molecule Watch team. Big Molecule Watch editor Cynthia Hardman will moderate the conversation during the day-two luncheon fireside chat, “Standing on the Front Lines: Trials…
On November 8, 2016, Amgen submitted a brief in opposition to Apotex’s petition for certiorari challenging the Federal Circuit’s application of its holding in Amgen v. Sandoz that subsection (l)(8)(A) of the BPCIA allows an aBLA applicant to provide notice of commercial marketing only after it receives approval, as well…
While Donald Trump’s victory has made world headlines, what may be less well known to our readers is that the election also gave Trump’s Republican Party majority control of both the House and the Senate. For the first time in many years, Republicans will control both the White House and…