Parties Agree That Mylan's Pegfilgrastim Biosimilar Does Not Infringe Amgen's Patent
August 29th 2019Amgen, 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.
Progress and Challenges in the US Biosimilar Space
August 28th 2019Editorial board member Brian Lehman, MBA, MHA, RPh, examines current progress and challenges that biosimilars face in the US context, and argues that stakeholders have the opportunity to be part of the solution to high drug prices by supporting biosimilars.
Revance Gives Mylan Additional Time to Decide on Botox Biosimilar Development
August 28th 2019In a filing with the US Securities and Exchange Commission this month, Silicon Valley-based biotech company Revance Therapeutics said that it has entered into an amendment to a Collaboration and License Agreement with Mylan; the amendment extends the period of time Mylan has to decide whether to continue to develop and commercialize a biosimilar of Allergan’s onabotulinumtoxinA (Botox).
Women More Likely Than Men to Ration Diabetes Meds Due to Cost, CDC Says
August 27th 2019Women are more likely than men not to take their diabetes medication as prescribed in an effort to control prescription drug costs, as are adults under age 65, according to a report published this month by the Centers for Disease Control and Prevention (CDC).
Japanese Study: CT-P13 Is Interchangeable With Remicade in Real-World IBD Treatment
August 27th 2019A Japanese postmarketing surveillance study of biosimilar infliximab CT-P13 (Inflectra, Remsima) concludes that the biosimilar and its reference, Remicade, are comparable in terms of efficacy and adverse drug reactions in patients with inflammatory bowel disease (IBD) and that the biosimilar is a cost-efficient option that is interchangeable with the reference in real-world practice.
Ahead of US Biosimilar Etanercept Competition, Amgen Acquires Apremilast
August 27th 2019Amgen announced yesterday that it will acquire apremilast (Otezla) from Celgene. The small-molecule drug, which inhibits phosphodiesterase 4, specific for cyclic adenosine monophosphate, is an orally administered therapy for patients with psoriatic arthritis and patients with plaque psoriasis who are candidates for phototherapy or systemic therapy.
Reducing Adjuvant Chemotherapy Dose Too Early May Impact Breast Cancer Survival
August 26th 2019Early dose reductions in the adjuvant chemotherapy combination of 5-fluorouracil, epirubicin, cyclophosphamide, and docetaxel negatively impacted survival rates for patients with intermediate- or high-risk breast cancer.
New Axial Spondyloarthritis Guideline Recommends Against Mandatory Switching to Biosimilars
August 26th 2019A more compelling rationale for switching medications—particularly in light of “marginal” cost savings provided by biosimilars in the United States—is necessary, says the guideline.
Global Coalition of Regulators Voices Confidence in Biosimilars
August 25th 2019The International Coalition of Medicines Regulatory Authorities, an executive-level coalition of regulators from 29 medicines regulatory authorities from territories including Australia, Brazil, Canada, China, the European Union, and the United States, among others, recently released a statement of confidence in biosimilars.
Dr. Reddy's Launches Bevacizumab Biosimilar in India, Eyes Emerging Markets Next
August 24th 2019In 2018, Dr. Reddy’s indicated that it expected to initiate clinical studies for the bevacizumab biosimilar to facilitate EU and US regulatory approval, but this week, a company representative told The Center for Biosimilars® in an email that, “currently, we are gearing up for filings in emerging markets for Versavo.”
Employers Could Reap Substantial Savings Through Biosimilars, but Not Without Targeted Effort
August 23rd 2019A new report from Matrix Global Advisors and the National Business Group on Health, sponsored by Boehringer Ingelheim, shows that employers could see substantial savings from biosimilars, but those savings won’t come without a concerted effort to encourage biosimilar use.
Ibrutinib, Rituximab for Patients With CLL Superior to Standard Chemoimmunotherapy
August 23rd 2019“These results will fully usher the treatment of chronic lymphocytic leukemia [CLL] into a new era,” said Tait Shanafelt, MD, professor of medicine at Stanford. “It seems likely that, in the future, these patients will be able to forego chemotherapy altogether.”
Study Looks Favorably at Adding Rituximab to Primary Central Nervous System Lymphoma Treatment
August 22nd 2019A recent study suggests that adding rituximab to a high‐dose methotrexate‐based combination chemotherapy could prolong overall survival as well as progression-free survival for patients with primary central nervous system lymphoma, a rare and aggressive form of lymphoma.
Eye on Pharma: Biocon's Insulin Facility Earns GMP Certification
August 22nd 2019Biocon has gained a certificate of good manufacturing practice (GMP) from the European Medicines Agency’s Irish inspection authority for its Malaysian manufacturing site where it produces its insulin glargine biosimilar, Semglee, referencing Lantus.
Patients With DLBCL See No Additional Gains With Maintenance Rituximab After CHOP
August 21st 2019A recent study found that rituximab maintenance therapy provides no additional benefit for patients with diffuse large B‐cell lymphoma (DLBCL) who are in complete remission after receiving rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) chemotherapy.
Fewer Than One-Third of New Patients With RA Receive Disease-Modifying Medications, Study Says
August 20th 2019Fewer than one-third of patients newly diagnosed with rheumatoid arthritis (RA) used anti–tumor necrosis factors agents, other biologics, Janus kinase inhibitors, or conventional disease-modifying antirheumatic drugs in 2014.
Gedeon Richter Launches Teriparatide Biosimilar in Europe
August 20th 2019Hungary-based Gedeon Richter announced today that it has launched a biosimilar teriparatide, Terrosa, in Europe. The drug, referencing Eli Lilly’s Forsteo (sold as Forteo in the United States), is used to treat osteoporosis. The product will also be sold under the brand name Movimya by the company's partner, Stada.
How Prepared Is the United States for the Transition of Insulins to Regulation as Biologics?
August 20th 2019While drug makers who sell insulin in the United States have had the past decade to prepare for the transition, stakeholders within the diabetes community must grapple with the potential impacts that this regulatory change could have.
Court of Appeals for the Federal Circuit Declines to Halt Sales of Biosimilar Bevacizumab
August 19th 2019In 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.
AbbVie Gains FDA Approval for Upadacitinib, Its Successor to Humira
August 19th 2019Upadacitinib is expected to help AbbVie continue to lead in the immunology market after biosimilar competition emerges for adalimumab in 2023. The approval for the treatment of RA is one of 6 indications that AbbVie’s chief executive officer, Richard Gonzalez, said in a 2018 presentation that the company expects to have approved and launched by 2022.
Cummings and Sanders Seek Pricing Information From 3 Generic Drug Makers
August 17th 2019Representative Elijah Cummings, D-Maryland, and Senator Bernie Sanders, I-Vermont, have sent letters to executives of 3 generic drug makers in which they ask for drug pricing information as part of a probe into the rising cost of generics.