Legal

Bipartisan ACCESS Act Would Eliminate Patient Co-payment for Biosimilars in Part B

October 2nd 2019

By Kelly Davio

A newly introduced item of legislation proposes to eliminate co-payments for patients when they receive a biosimilar rather than an originator biologic in Medicare Part B.

Can Congress Speed Biosimilars to Market by Limiting Patent Litigations?

September 30th 2019

Using 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 2019

By Kelly Davio

In 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 2019

By Kelly Davio

In 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 2019

By Kelly Davio

The 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.

In Agreement With Genentech, JHL Must Destroy Its Biosimilar Cell Lines and Banks

September 6th 2019

By Kelly Davio

Genentech has reached a memorandum of understanding with JHL Biotech in its civil lawsuit related to the theft of Genentech’s trade secrets.

PTAB Will Review Key Patents on Brand-Name Eculizumab, Soliris

September 3rd 2019

By Kelly Davio

Last 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 2019

By Kelly Davio

Amgen, 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 2019

By Kelly Davio

In 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.

In Long-Awaited Decision in Etanercept Litigation, Court Sides With Amgen Over Sandoz

August 12th 2019

By Kelly Davio

A judge for the United States District Court for the District of New Jersey has ruled in favor of Amgen in a long-running patent litigation concerning Sandoz’s biosimilar etanercept, Erelzi.