True North $100-Million Investment in Biocon Biologics Kicks Off New Fundraising Round
January 7th 2020Indian private equity firm True North could soon hold a 2.44% minority stake in Biocon Biologics India Ltd, a subsidiary of Biocon Ltd, thanks to a $100-million investment. The influx of cash values Biocon Biologics at close to $3 billion. The investment is pending regulatory approval.
Spectrum Says Its Novel G-CSF Drug Will Be Reviewed by FDA
January 4th 2020In late December, Spectrum Pharmaceuticals announced that the FDA has accepted for review a Biologics License Application for eflapegrastim, a novel drug that could, if approved, compete with existing granulocyte colony-stimulating factor (G-CSF) therapies and their biosimilars.
Gilead Submits JAK Inhibitor, Filgotinib, Under Priority Review for Rheumatoid Arthritis
January 2nd 2020Last month, Gilead Sciences submitted a New Drug Application (NDA) to the FDA for filgotinib under the priority review process. Filgotinib is a Janus kinase (JAK) inhibitor aimed at moderate-to-severe rheumatoid arthritis (RA).
Risk of New IBD Rises for Patients Treated With Etanercept
January 1st 2020While anti–tumor necrosis factor (anti-TNF) drugs are effective at treating a range of inflammatory diseases, some limited data suggest that they may, paradoxically, result in a higher risk of developing other de novo inflammatory conditions.
5 of the Biggest Controversies in Biosimilars in the Year 2019
January 1st 2020With drug costs continuing to spiral and slower uptake in the United States compared to other parts of the world, it is perhaps natural for observers of biosimilars to ask questions, not only about well-known patent issues, but about deeper issues, such as the way biosimilars are developed, the meaning of interchangeability, and perhaps the very structure of the industry itself. Here’s a look at 5 hot topics from 2019.
Meta-Analysis Finds No Increased Mortality for Patients Treated With Intravitreal Anti-VEGFs
December 30th 2019Intravitreal injection with anti–vascular endothelial growth factor (anti-VEGF) drugs has represented a major step forward for patients with retinal diseases, and the upcoming biosimilars market for these drugs—including aflibercept and ranibizumab, as well as off-label bevacizumab—is beginning to take shape. However, there have been some lingering concerns about the safety of these drugs, as increased mortality has been reported after anti-VEGF treatment in the general population.
The Most Listened-to Podcast Episodes of 2019
December 30th 2019During 2019, The Center for Biosimilars® provided interviews and discussions with key opinion leaders on our podcast to discuss various issues affecting biosimilars. From patent issues to the arrival of oncology biosimilars, here is a look at our top 5 podcast episodes from 2019.
Low-Dose Rituximab May Be Cost-Effective for Myasthenia Gravis
December 28th 2019Autoimmune myasthenia gravis is typically treated with surgery, acetylcholine esterase inhibitors, corticosteroids, and immunosuppressive drugs like azathioprine and mycophenolate mofetil. Some patients have refractory disease and may require therapies like eculizumab (Soliris), which, while effective, is a particularly high-cost biologic that has no approved biosimilars in Europe or the United States, although biosimilars are advancing through clinical development. Rituximab, however, which is lower-cost than eculizumab and has multiple approved biosimilars, has also emerged as a promising treatment.
Switching Back to Reference Infliximab From Biosimilar Appears Effective for Patients With IBD
December 27th 2019At the United European Gastroenterology Week 2019, held in Barcelona, Spain, earlier this year, a research team from the Netherlands reported on the prevalence of patients with inflammatory bowel disease (IBD) switching back to the reference infliximab after a previous switch to biosimilar CT-P13, and found that switching back appeared to be effective in patients with IBD.
The Most-Read Contributor Articles of 2019
December 26th 2019In 2019, readers of The Center for Biosimilars® gravitated toward content reflecting the future of the market. Contributors from Amgen and Coherus BioSciences drew in readers with their assessments of new developments and practices to increase savings for patients, while other contributors took a look at how FDA guidelines will impact biosimilars.
The Most-Watched Interviews of 2019
December 25th 2019This year, interviews with industry experts were the most popular among readers of The Center for Biosimilars. Touching on topics like market performance, cost, and government regulations, officials and professionals weighed in on the debates surrounding biosimilars and offered their opinions on how the industry can improve.
Time for Plans to Shoulder More Risk in Medicare Part D?
December 24th 2019Among the features of the Part D structure is a federal reinsurance program in which, when a beneficiary reaches the catastrophic threshold in a given year, the government subsidizes 80% of remaining spending for the year. Part D plans pay 15%, and patients pay 5% in this scenario.
AstraZeneca, Daiichi Sankyo Win FDA Approval for Trastuzumab Antibody Conjugate
December 23rd 2019AstraZeneca and Daiichi Sankyo said Monday they received FDA approval for their [fam-] trastuzumab deruxtecan-nxki, which will be marketed as Enhertu. [Fam-] trastuzumab deruxtecan is an antibody–drug conjugate (ADC) designed to delivery cytotoxic chemotherapy to cancer cells via a human epidermal receptor 2 (HER2) antibody attached to a novel topoisomerase I inhibitor payload and a tetrapeptide-based linker.
A Large Proportion of Suboptimal Responders With Axial Spondyloarthritis Remain on Anti-TNF Agents
December 23rd 2019At 6 months and 1 year, respectively, survival rates among the suboptimal responders who stayed on their index anti–tumor necrosis factor (anti-TNF) agent were 90.2% and 85.1%, respectively.
Post-Induction Levels of MMP3 Can Predict Loss of Response to Infliximab in IBD
December 23rd 2019It has been hypothesized that metalloproteinases, and particularly MMP3, could a have a role in degrading anti–tumor necrosis factor drugs, leading to treatment failure in patients with inflammatory bowel disease (IBD).