Regulatory

Earlier this month, a federal appeals court heard arguments in Texas v Azar. If the judge sides with the Republican point of view that the entire Affordable Care Act (ACA) is unconstitutional and invalidates the landmark law, the Biologics Price Competition and Innovation Act (BPCIA), the pathway for biosimilars included in the ACA, would have to start over from scratch. That shouldn’t be a problem, according to 2 conservative healthcare and pharmaceutical observers interviewed by The Center for Biosimilars®.

Genentech had asked the court for a temporary restraining order and a preliminary injunction against Amgen in a Biologics Price Competition and Innovation Act (BPCIA) litigation related to patents covering Herceptin. The United States District Court for the District of Delaware denied Genentech’s motion, and the court has now made public a redacted version of the memorandum opinion in the matter.

The FDA has approved Pfizer’s rituximab biosimilar, Ruxience (rituximab-pvvr), referencing Rituxan. The biosimilar was approved to treat non-Hodgkin lymphoma, chronic lymphocytic leukemia, and granulomatosis with polyangiitis and microscopic polyangiitis.

"We argue that the default should be that biosimilars are interchangeable, unless there is compelling evidence otherwise," write Hans C. Ebers, PhD, of Biogen, and Hubb Schellekens, MD, PhD, of Utrecht University.

Senator Ted Cruz, R-Texas, has reintroduced a bill he thinks will speed US approval of drugs, biologics, or devices approved in other countries.

Samsung Bioepis has announced that the European Medicines Agency (EMA) has accepted for review its market authorization application for SB8, a proposed bevacizumab biosimilar referencing Avastin.

At the beginning of this year, we spoke with Laura Joszt, associate editorial director and the host of The American Journal of Managed Care’s podcast, Managed Care Cast, about where biosimilars stood at the end of 2018. Now, halfway through the year, we’re continuing that conversation with a look at how biosimilars have fared so far in 2019.

When the Senate Committee on Health, Education, Labor, and Pensions released bipartisan legislation aimed at lowering the cost of healthcare in the United States in May, biosimilar stakeholders had some cause for optimism. However, one provision of the bill that has garnered significantly less attention from the broader healthcare community has raised concerns among many biologics stakeholders.

The Center for Biosimilars® recaps the top stories for the week of July 15, 2019.

According 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.

The FDA has released updated draft guidance on population pharmacokinetics (PK). The update follows draft guidance originally put forth by the agency in 1999.

The Center for Biosimilars® recaps the top stories for the week of July 8, 2019.

Biosimilar developer Biocon is facing yet another setback after the FDA issued another Form 483 for its insulin facility.

The United States District Court for the District of Columbia has vacated the Trump administration’s rule requiring the disclosure of wholesale acquisition costs for drugs in direct-to-consumer television advertising. The rule had been slated to take effect today, July 9.

Biosimilar developer Samsung Bioepis has gained an updated label for its biosimilar adalimumab, Imraldi, referencing Humira. The biosimilar is now approved for storage in nonrefrigerated conditions for up to 28 days. This update means that the biosimilar can now be stored for an additional 2 weeks at room temperature.

The European Commission approved ravulizumab (Ultomiris) for adults with paroxysmal nocturnal hemoglobinuria.

The Center for Biosimilars® recaps the 5 most-read stories of 2019 to date.

Industry insiders discuss current trends about the patent dance and other issues, as well as proposed legislation that could affect biosimilar development.

The FDA has approved Pfizer’s bevacizumab biosimilar, bevacizumab-bvzr, referencing Avastin.

The Center for Biosimilars® recaps the top stories for the week of June 24, 2019.

Alexion Pharmaceuticals’ brand-name eculizumab (Soliris) gained its fourth approval, this time for the treatment of neuromyelitis optica spectrum disorder (NMOSD).

Courts will be busy with biosimilar litigation for the foreseeable future, attorneys predicted at a panel on the second day of the ACI 10th Summit on Biosimilars.

The FDA today announced a proposed rule that would amend regulations concerning the use of master files for biologics. According to the FDA, this rule is necessary to avoid any disruption to products that will transition from regulation as drugs to regulation as biologics in 2020.

Eli Lilly and Company, together with partner Innovent Biologics, announced today that China’s National Medical Products Administration will review its application for IBI301, a proposed rituximab biosimilar referencing MabThera and Rituxan.

The Biosimilars Council, a part of the Association for Accessible Medicines, has issued a new white paper in which it condemns abuses of the patent system that delay biosimilar competition. It also argues that legislative proposals to regulate settlements would “merely benefit companies investing in the creation of patent thickets.”

Under 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.

With a variety of policy ideas circulating around Washington, DC, in regards to stimulating biosimilar competition and lowering drug prices, the role of the FDA is to provide technical assistance to those legislative staffers and others looking for information, a key FDA official told a packed audience at the ACI 10th Summit on Biosimilars on Monday in New York City.

China-based drug maker Henlius has announced that the European Medicines Agency (EMA) has accepted for review the company’s marketing authorization application for a trastuzumab biosimilar, HLX02, referencing Herceptin.

Drug maker Alexion, developer of the rare disease drug eculizumab (Soliris), announced Friday that the FDA has accepted for priority review its long-acting C5 complement inhibitor, ravulizumab (Ultomiris), which offers less frequent administration than eculizumab.

The attributes for the N-glycan profile, FcγRIIIa binding activity, and relative antibody-dependent cell-mediated cytotoxicity (ADCC) activity for the reference trastuzumab resulted in reduced ADCC and FcγRIIIa binding activities.