March 6th 2024
Biocon Biologics settled with the maker of Eylea (aflibercept), announcing a launch date for its biosimilar competitor in Canada; Sandoz has officially acquired Cimerli, a ranibizumab biosimilar; AARP Medicare Rx from United Healthcare has added Cyltezo (adalimumab-adbm) and removed the originator (Humira) from its formulary.
Patent Thickets Are Not the Obstacle They Appear to Be, BIO Patent Counsel Claims
March 14th 2020Seen up close, many patents are not truly strong enough to block biosimilar commercialization, although patents filed after FDA approval of originator products can bar access to modern manufacturing methods, according to Hans Sauer, deputy general counsel and vice president for intellectual property at the Biotechnology Innovation Organization (BIO).
Supreme Court to Rule on ACA's Fate After 2020 Election
March 3rd 2020The Supreme Court will hear an appeal by a coalition of 20 mainly Democratic states, which are hoping for a reversal of a Fifth Circuit Court of Appeals ruling that held the Affordable Care Act’s (ACA) individual mandate is unconstitutional and called into question whether the remaining provisions of the law could still stand. However, a decision will not come until after the November 2020 presidential election.
Appeals Court Rules J&J Must Face Infliximab Antitrust Suit Brought by Walgreens, Kroger
February 26th 2020Antitrust claims are a product of federal statute, said the Third Circuit Court of Appeals, in reinstating a Walgreens and Kroger antitrust lawsuit against J&J over its branded infliximab, Remicade.
Biosimilar Pipeline Congested by Patent Litigation Bottleneck
February 11th 2020The orphan drug market could see hefty biosimilar competition, based on revenue potential, and patent struggles need to be resolved before some biosimilars can come to market, according to a speaker reviewing the 2020 pipeline at the Specialty Therapies and Biosimilars Congress.
Biosimilar Makers Must Plan for Originator Firms Gaming the Patent System, Panel Says
January 22nd 2020It’s important to keep in mind the successive patents that can be filed to keep an original product in a position of market dominance, and drug descriptions in biologic license applications can be written cleverly to achieve this aim, according to a panelist speaking at the Specialty Therapies and Biosimilars Conference, happening January 22-24, 2020, in Miami, Florida.
US Biosimilar Launches, Stymied by Manufacturer Opposition, Continue to Struggle, Analysis Finds
January 14th 2020In the United States, recent analyses show that biosimilars achieved just 9%, or $91 million, of the $1 billion in cost savings that the Congressional Budget Office projected 10 years ago.
Lobbying Group Appeals Decision Allowing California Pay-for-Delay Law to Take Effect
January 9th 2020The law made California the first state to bar pay-for-delay pharmaceutical agreements by making them presumptively anticompetitive if the nonreference drug maker receives anything of value from the other company.
Little Impact Post-Arthrex for Biologic Patents at the PTAB
December 3rd 2019The Federal Circuit, in Arthrex, Inc v Smith & Nephew, Inc, ruled that the appointment of Administrative Patent Judges (APJs) at the Patent Trial and Appeal Board (PTAB) violated the Appointments Clause of the US Constitution, and held that APJs could be removed from office without cause. Absent a dramatic ideological shift in the PTAB, however, this decision likely will have little impact on how follow-on biologics developers use inter partes review (IPR).
FDA Says a "Broken Marketplace" to Blame for Drug Shortages
October 30th 2019Given how markets operate, pharmaceutical companies need financial incentives in order to keep providing a reliable stream of high-quality products that otherwise, due to low prices and other factors, might fall into shortage, according to an FDA report about the drug shortages problem released this week.
Bipartisan Patent Transparency Bill Introduced in House of Representatives
October 28th 2019A bipartisan bill to require patent transparency in an effort to bring down the cost of prescription drugs has been introduced in the House of Representatives; the bill is a piece of companion legislation to one introduced in the Senate in March.
AbbVie Says Antitrust Case Over Humira Could "Chill Medical and Therapeutic Innovation"
October 16th 2019In a memorandum in support of its motion to dismiss the suit, AbbVie says that the complaint seeks to “upend the well-settled balance between the patent and antitrust laws,” that the complaint would end international early-entry patent settlements that do not have the same global market entry date, and that it would “chill medical and therapeutic innovation.”
Nevada Tells 21 Diabetes Drug Makers They Owe $17.4 Million for Violating Transparency Law
October 7th 2019The state’s Department of Health and Human Services this week sent letters to firms that did not provide required information about production costs, marketing and advertising costs, patient assistance programs, wholesale acquisition costs, and historical increases, among other information.
Can Congress Speed Biosimilars to Market by Limiting Patent Litigations?
September 30th 2019Using data compiled for BiologicsHQ.com, we analyzed 2 bills that propose changes to patent litigation by limiting the number of patents a reference product sponsor can assert in a patent litigation to see how many biosimilar cases they would have impacted so far and whether they would really help bring biosimilars to market sooner.
Pfizer Confirms It Plans to Launch Bevacizumab Biosimilar on December 31
September 30th 2019In an email to The Center for Biosimilars®, a Pfizer representative said that, after having agreed to the terms of a settlement with Genentech and Roche that provides the biosimilar developer with global licenses for its product, Pfizer plans to launch its biosimilar bevacizumab, Zirabev, in the US market on December 31, 2019.
Arrow Declarations Are an Emerging Feature in the Biosimilar Patent Landscape
September 27th 2019In the US context, legal issues surrounding patents are often cited as one of the main hurdles to biosimilars. Despite the fact that patents on innovator drugs are often fewer in Europe, the patent landscape in the European Union remains complex and continues to evolve. During the SMi 10th Annual Biosimilars Conference, Gregory Bacon, DPhil, GDipIPLaw, partner at Bristows LLP, gave attendees a closer look at one emerging feature of the EU patent landscape that is of particular concern to biosimilar developers: the Arrow declaration.
In Antitrust Case Over Remicade, J&J Wins the Right to Arbitration
September 16th 2019The United States Court of Appeals for the Third Circuit has sided with Johnson & Johnson (J&J) and its Janssen division, requiring a dispute between the Remicade maker and Rochester Drug Cooperative to be sent to arbitration.
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.