Business

The Top 5 Biosimilars Articles for the Week of September 30

October 4th 2019

The Center for Biosimilars® recaps the top stories for the week of September 30, 2019.

Biocon and Mylan Launch Insulin Glargine Biosimilar in Australia

October 3rd 2019

By Kelly Davio

Biocon and Mylan have launched their biosimilar insulin glargine, Semglee, in Australia. The general schedule for Semglee lists the biosimilar as “a-flagged,” a designation that allows a product to be substituted at the pharmacy level without consulting with the prescribing physician.

AARP, HHS File Briefs in DTC Case Over Drug Prices

October 2nd 2019

By Allison Inserro

The case over whether drugmakers can be compelled to disclose pharmaceutical prices in direct-to-consumer (DTC) television advertisements continues in the US Court of Appeals for the District of Columbia, with HHS appealing and AARP and the AARP Foundation filing an amicus brief this week in Merck & Co. Inc. et al v US Department of Health and Human Services et al.

Novartis to Seek a Fourth Indication for Secukinumab

October 2nd 2019

By The Center for Biosimilars Staff

Drug maker Novartis announced that it will seek a fourth indication—nonradiographic axial spondyloarthritis (nr-axSpA)—for its secukinumab (Cosentyx) in the United States after its phase 3 PREVENT trial met its 52-week primary end point.

Rituxan Gets Approval for 2 Pediatric Vasculitis Conditions

September 30th 2019

By Allison Inserro

The FDA has approved another indication for reference rituximab (Rituxan), this time for children with rare vasculitis diseases.

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.

The Top 5 Biosimilars Articles for the Week of September 23

September 27th 2019

The Center for Biosimilars® recaps the top stories for the week of September 23, 2019.

Biosimilar Developers Have the Chance to Innovate With Device Design, Novartis Leader Says

September 26th 2019

By Kelly Davio

Innovation is not always the first term that comes to mind with respect to biosimilars; after all, having no clinically relevant differences between products is at the heart of biosimilarity. However, as Sebastian Maag, device project leader for Novartis–Sandoz GmbH, told attendees during the second day of the SMi 10th Annual Biosimilars Conference, biosimilar developers have the opportunity to introduce innovations with the design of their devices for drug delivery.

With Brexit Looming, What Does the Future Hold for UK Biosimilars?

September 26th 2019

By Kelly Davio

If and when the United Kingdom leaves the European Union, the Medicines and Healthcare Products Regulatory Agency is poised to provide its own review structure for biosimilars.

IQVIA Analyst Looks at Current Developments and the Decade Ahead for Biosimilars

September 25th 2019

By Kelly Davio

The global biosimilars market is beginning to take on a more defined shape as blockbuster therapies lose their exclusivities, the United States sees the entrance of the first anticancer biosimilars, and Europe gains experience and savings with adalimumab biosimilars. But what will the coming decade hold in terms of new development projects and global sustainability?