October 15th 2024
Regeneron appeals legal decision after judge refuses to block an aflibercept biosimilar; Prime Therapeutics, a pharmacy benefit manager (PBM), becomes the latest to offer biosimilars referencing Humira (adalimumab) at a low cost; the FDA and European Medicines Agency accept a denosumab biosimilar candidate for review.
PTAB Will Review Key Patents on Brand-Name Eculizumab, Soliris
September 3rd 2019Last week, the Patent Trial and Appeal Board (PTAB) instituted 3 inter partes review proceedings concerning patents on Alexion’s brand-name eculizumab, Soliris, a complement inhibitor that treats rare diseases. Amgen is the petitioner in all 3 cases, which were filed in February of this year.
Parties Agree That Mylan's Pegfilgrastim Biosimilar Does Not Infringe Amgen's Patent
August 29th 2019Amgen, maker of the brand-name pegfilgrastim (Neulasta), and Mylan, which partnered with Biocon to develop a biosimilar (Fulphila), have entered a joint status report in the District Court for the Western District of Pennsylvania.
Court of Appeals for the Federal Circuit Declines to Halt Sales of Biosimilar Bevacizumab
August 19th 2019In a one-page order filed last week, a panel of judges for the US Court of Appeals for the Federal Circuit denied Genentech’s motion for an injunction that would have blocked Amgen from selling its biosimilar bevacizumab, Mvasi, pending the outcome of an appeal.
CBO Says Lower Health Care Costs Act Could Save $7.6 Billion by 2029
July 17th 2019According to the Congressional Budget Office (CBO), enacting the bill would increase direct spending by about $18.7 billion and increase direct revenues by $26.2 billion, resulting in a net decrease in the deficit of $7.6 billion by 2029.
UK Patent Court Delivers Setback to Biosimilar Bevacizumab Launch
June 26th 2019In this case, Pfizer hoped to launch its biosimilar bevacizumab in the UK market after the basic patent on the reference product, Genentech and Roche’s Avastin, expires in June 2020. However, the biosimilar maker has been hindered by what it has termed a patent thicket related to secondary patents.
When Can Biologic Patent Disputes Go Before the ITC?
June 25th 2019Under which situations might the International Trade Commission (ITC) be the right choice for biosimilar patent disputes instead of federal district court? A panel discussed these questions at the ACI 10th Summit on Biosimilars on Monday in New York City.
Amgen Settles With One Biosimilar Developer, Sues Another
May 6th 2019Last week, biosimilar developer Coherus BioSciences announced that it has reached a settlement with innovator drug maker Amgen over a trade secret case that was pending in the Superior Court of California. Separately, Amgen filed a new complaint against biosimilar developer Samsung Bioepis.
PBMs Under Pressure From New Legislation and Fresh Lawsuits
April 24th 2019Earlier this month, pharmacy benefit managers (PBMs) were called before the Senate Finance Committee to answer questions about how their businesses impact drug prices for Americans. While the executives deflected criticism and pointed to issues like legal challenges to biosimilars as playing a key role in keeping drug prices high, lawmakers and officials are taking steps to rein in PBMs.
Judge Grants BI's Motion to Compel AbbVie to Produce Documents in Ongoing Humira Litigation
April 18th 2019This month, US magistrate judge Richard A. Lloret granted Boehringer Ingelheim (BI)’s motion to compel AbbVie to produce prelitigation disclosures and settlements concerning its brand-name adalimumab, Humira.
Class Action Lawsuit Filed Against AbbVie and Biosimilar Developers Alleges Collusion
March 19th 2019A class action lawsuit has been filed by United Food and Commercial Workers Local 1500 (UFCW Local 1500) against AbbVie for alleged use of a patent thicket to maintain a monopoly for its brand-name adalimumab, Humira. The complaint also alleges that AbbVie and a number of its biosimilar competitors colluded to divide the market for adalimumab between Europe and the United States.
Ahead of an FDA Decision on Its Pegfilgrastim Biosimilar, Sandoz Sues Amgen
February 26th 2019This month, biosimilar developer Sandoz filed suit against Amgen, asking the United States district court for the Northern District of California for a declaratory judgment of patent noninfringement and invalidity.
In a Win for Boehringer Ingelheim, AbbVie Must Turn Over Humira Documents
February 12th 2019In a long-running patent dispute with biosimilar developer Boehringer Ingelheim, AbbVie, maker of the brand-name adalimumab, Humira, has been ordered to produce documents related to its efforts to obtain patents that could shield its blockbuster drug from biosimilar competition.
Court Rules That Momenta's Abatacept Appeal Is Moot
February 8th 2019This week, the United States Court of Appeals for the Federal Circuit found that Momenta lacked standing to appeal a decision upholding a patent covering abatacept (Orencia) and said that Momenta’s appeal was rendered moot by the drug makers’ choice to stop developing its biosimilar.
Coherus Settles With AbbVie, Sues Amgen, Over Biosimilar Adalimumab
January 28th 2019Coherus BioSciences announced on Friday that it has become the latest biosimilar developer to settle with AbbVie, maker of the brand-name adalimumab, Humira, over a proposed biosimilar. In an intellectual property twist, Coherus also announced that it has sued a rival biosimilar developer, Amgen.
With the Future of the ACA in Question, Are US Biosimilars at Risk?
December 19th 2018While many stakeholders are concerned most immediately about how a recent ruling on the Affordable Care Act (ACA) could affect US patients’ healthcare options and coverage for pre-existing conditions, the biosimilars industry is also concerned about the future of one key feature of the ACA that keenly impacts the biosimilars landscape: the Biologics Price Competition and Innovation Act.
Republican Lawmakers Introduce Bill to Limit IPRs by Generic and Biosimilar Developers
December 18th 2018Last week, Republicans in the House of Representatives and in the Senate introduced legislation that would restrict generic and biosimilar developers from challenging patents on reference drugs using the inter partes review (IPR) process.