The Center for Biosimilars Staff

September 20, 2019

The FDA this week finalized industry guidance intended to stop citizen petitions used by brand-name drug makers to delay the market entry of generics or biosimilars of branded products.

September 19, 2019

By providing time-saving options for treatment, Roche may be able to secure market share for its innovator biologics if savings in terms of chair time for patients are able to offset the eventual price discounts made available by biosimilar developers for their products.

September 14, 2019

Kaiser Health News, in its latest update to its campaign contributions tracking tool, reports that Senator Chris Coons, D-Delaware, received the most contributions from the pharmaceutical industry during the first half of 2019, at $103,000. Coons, together with Senator Thom Tillis, R-North Carolina, who himself received $102,000 this cycle, released a draft of a patent reform bill in May, and concerns among drug makers about the eventual passage of that bill have run high.

September 14, 2019

The Institute for Clinical and Economic Review (ICER) said this week it will review the comparative clinical effectiveness and value of therapies for ulcerative colitis, including the reference infliximab product from Johnson & Johnson and biosimilar infliximab from Pfizer.

September 12, 2019

Insulin maker Novo Nordisk has announced that, in January of 2020, it will launch authorized generics of its NovoLog (insulin aspart) and NovoLog Mix (insulin aspart protamine and insulin aspart) products. Notably, the authorized generics will become available before the March 2020 transition of insulins to regulation as biologics and biosimilars rather than drugs and generics.

September 10, 2019

Patient organizations for those with inflammatory bowel disease (IBD) are upset with the government of British Columbia for a plan to shift patients to biosimilars over the next 6 months.

September 10, 2019

Republic of Korea–based biosimilar developer Celltrion has announced that its trastuzumab biosimilar, CT-P6, which it markets as Herzuma, has received authorization from Health Canada.

September 10, 2019

It is already understood that a longer disease duration and delays in using disease-modifying antirheumatic drugs (DMARDs) in patients with rheumatoid arthritis (RA) is associated with worse disease control, but a new study, published just last month, has shown that the number of conventional DMARDs used before starting anti–tumor necrosis factor (anti-TNF) therapy could reduce the magnitude of a patient’s response to anti-TNFs like adalimumab.

September 08, 2019

Janssen, a unit of Johnson & Johnson, announced this week that the European Commission has approved its ustekinumab (Stelara) for the treatment of moderate to severe ulcerative colitis. Also approved in the European Union to treat plaque psoriasis, psoriatic arthritis, and Crohn disease, the biologic is the first available therapy that targets the interleukin-12 and -23 pathway.

September 07, 2019

Iceland-based Alvotech and Singapore-based Prestige Biopharma have entered a contract manufacturing partnership for Prestige’s biosimilars.