Patel: Biosimilar Education Can Be ChallengingMarch 21st 2020
Kashyap B. Patel, MD, has worn many hats in the struggle to broaden biosimilar access. He is an independent oncology practitioner, a member of the Community Oncology Alliance (COA), and a representative of International Oncology Network (ION) Solutions, a large drug purchasing organization. Bringing biosimilars to a broader population of patients has involved negotiations with payers, persistence on Capitol Hill, and education, he explains in an interview.
Supreme Court to Rule on ACA's Fate After 2020 ElectionMarch 3rd 2020
The Supreme Court will hear an appeal by a coalition of 20 mainly Democratic states, which are hoping for a reversal of a Fifth Circuit Court of Appeals ruling that held the Affordable Care Act’s (ACA) individual mandate is unconstitutional and called into question whether the remaining provisions of the law could still stand. However, a decision will not come until after the November 2020 presidential election.
Appeals Court Rules J&J Must Face Infliximab Antitrust Suit Brought by Walgreens, KrogerFebruary 26th 2020
Antitrust claims are a product of federal statute, said the Third Circuit Court of Appeals, in reinstating a Walgreens and Kroger antitrust lawsuit against J&J over its branded infliximab, Remicade.
No Higher Risk of Cancer for Patients With Psoriasis Treated With Biologics, Analysis FindsFebruary 19th 2020
The review found no increased risk of cancer when looking at both keratinocyte cancer and lymphomas in patients on biologics vs conventional therapy. Overall, however, patients with psoriasis appear to have a slightly increased risk of certain cancers.
Eye on Pharma: Phase 3 Trial of Bio-Thera Solutions' BAT1706 Yields Positive ResultsFebruary 6th 2020
Bio-Thera Solutions announced that a phase 3 clinical trial comparing the efficacy and safety of its bevacizumab biosimilar, BAT1706, to the reference product (Avastin), returned positive top-line results.
Vizient Says It Supports FDA Plan for Insulin Biosimilars, Interchangeable InsulinsJanuary 29th 2020
The guidance document provides recommendations as to whether—and when—comparative clinical immunogenicity studies will be needed to support an application to the FDA for insulin products under the biosimilar approval pathway.
Pfizer Touts Lower WAC of 3 Oncology Biosimilars as It Launches Rituximab ProductJanuary 24th 2020
Pfizer said it expects its 3 oncology biosimilar products to have the lowest wholesale acquisition cost among currently available bevacizumab, rituximab, or trastuzumab biosimilars. Its latest, Ruxience, referencing Rituxan, launched Thursday.
Lobbying Group Appeals Decision Allowing California Pay-for-Delay Law to Take EffectJanuary 9th 2020
The law made California the first state to bar pay-for-delay pharmaceutical agreements by making them presumptively anticompetitive if the nonreference drug maker receives anything of value from the other company.
Gilead Submits JAK Inhibitor, Filgotinib, Under Priority Review for Rheumatoid ArthritisJanuary 2nd 2020
Last 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).
Low-Dose Rituximab May Be Cost-Effective for Myasthenia GravisDecember 28th 2019
Autoimmune 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.
A Large Proportion of Suboptimal Responders With Axial Spondyloarthritis Remain on Anti-TNF AgentsDecember 23rd 2019
At 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.
Eye on Pharma: Meiji and Dong-A Begin Phase 1 Trial of Proposed Ustekinumab BiosimilarDecember 21st 2019
Japan-based Meiji Seika Pharma and Republic of Korea-based Dong-A Socio Holdings announced this month that they have started a phase 1 clinical trial of DMB-3115, a proposed ustekinumab biosimilar referencing Stelara.
Biosimilar Competition Has Led to "Marked Reductions" in Biologics' Net Prices, Study FindsDecember 19th 2019
The promise of biosimilars is that these subsequent-entry products can reduce the cost of biologic therapy by offering lower-priced alternatives that do not compromise efficacy or safety. An additional benefit is that the presence of competition in the marketplace can also drive down costs for originator products, or at least curb price growth, though to what degree biosimilars have had such an impact on originator biologics in the US market has not been fully elucidated.
Bispecific Antibody Outperforms Adalimumab in Phase 3 Study in PsoriasisDecember 17th 2019
No biosimilar adalimumab launches are currently announced for the US market prior to 2023 as a result of patent settlements struck between biosimilar developers and Humira’s maker, AbbVie, and new data show that innovative biologics currently being developed may be able to provide superior benefits versus the older adalimumab product that may make biosimilars of this therapy less appealing treatment choices.
Pfizer's Biosimilar Adalimumab Receives Positive CHMP OpinionDecember 16th 2019
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Pfizer’s biosimilar adalimumab referencing Humira. The product, which Pfizer proposes to market under the name Amsparity, will now be reviewed by the European Commission before it receives final marketing authorization.
Susan G. Komen Releases Patient Guide to BiosimilarsDecember 12th 2019
Organizations are releasing patient education materials about what biosimilars are, what questions patients should ask, and other things they might want to know. The latest such example comes from Susan G. Komen, which recently released a guide to using biosimilars and biologics for breast cancer.
AffaMed Gets Chinese Clearance to Start Phase 3 Trial of Biosimilar Trastuzumab, SB3December 11th 2019
AffaMed Therapeutics announced this week that it has received a Clinical Trial Application (CTA) approval from Chinese regulators to conduct a phase 3 clinical trial of Samsung Bioepis’ biosimilar trastuzumab, SB3.
Biosimilar Trastuzumab, Ogivri, and Its Reference in Combination With Pertuzumab Show Similar ActivityDecember 10th 2019
While biosimilars approved by regulators have been shown to have no clinically meaningful differences from their reference products, this week, during the San Antonio Breast Cancer Symposium, held in San Antonio, Texas, researchers will report reassuring data for biosimilar trastuzumab, Ogivri, showing that the combination of the biosimilar with pertuzumab is highly similar to the combination of the reference drug with pertuzumab.
Eye on Pharma: Alvotech and Kamada Team Up to Commercialize Biosimilars in IsraelDecember 7th 2019
Israel-based Kamada Ltd announced this week that it has entered into an agreement with Iceland-based Alvotech to commercialize 6 biosimilar products in Israel once the products gain local regulatory approval.