European Regulators Are Open to Novel Strategies in Biosimilar Development, Review Finds
May 2nd 2018Though the European Medicines Agency (EMA) has instituted guidelines for the development of biosimilars, approval of these drugs is possible even in cases in which the guidelines are not followed, and even in which primary endpoints in studies are not met.
Study: Biosimilar Filgrastim Can Improve Patient Access to FN Prophylaxis
May 1st 2018Filgrastim, used to prevent febrile neutropenia (FN) in patients undergoing chemotherapy, is the first drug in the United States to have a biosimilar approved. While the biosimilar filgrastim was approved in 2015, few studies have compared the real-world incidence of FN, healthcare resource utilization, and costs among US patients using the reference product (Neupogen) and those using the approved biosimilar (Zarxio).
Research Highlights Evolving Approaches to Biosimilars in the United States
April 30th 2018At the Academy of Managed Care Pharmacy’s Managed Care & Specialty Pharmacy Annual Meeting, held April 23 to 26, in Boston, Massachusetts, several research teams presented posters relevant to the US adoption of biosimilars.
Real-World Data Show Suboptimal Response to Anti-VEGF Agents in Macular Edema
April 26th 2018Retinal vein occlusion (RVO) is a prevalent, vision-threatening disease, of which macular edema is a common complication. Standard treatment for RVO-associated macular edema involves intravitreal treatment with anti–vascular endothelial growth factor (anti-VEGF) agents such as ranibizumab, bevacizumab, or aflibercept. Despite success with these agents in clinical trials, anti-VEGF agents may be administered less frequently in clinical practice than in studies.
Eye on Pharma: Biogen Will Increase Its Stake in Samsung Bioepis
April 26th 2018Jeffrey Capello, executive vice president and chief financial officer, divulged that Biogen intends to exercise its option to increase its stake in the Samsung Bioepis joint venture. Currently, Samsung BioLogics holds 94.6% of the company, and Biogen owns the remaining 5.4%.
Nicholas Mitrokostas, JD, Responds to Changes to IPRs in the Biosimilars Context
April 25th 2018While all eyes were on the Supreme Court of the United States’ ruling in the much-anticipated Oil States Energy Services, LLC, v Greene’s Energy Group, LLC, the Court issued a second key ruling this week in SAS Institute v Iancu, Director, United States Patent and Trademark Office, et al—one that will also impact inter partes review (IPR) of biologic drug patents.
EFCCA Report Highlights Unequal Access to Biologics and Biosimilars for IBD
April 25th 2018The European Federation of Crohn’s and Ulcerative Colitis Associations (EFCCA), an umbrella organization that represents 34 patient associations around the world, recently released a report on healthcare inequities among nations and regions. In the report, the EFCCA identified disparities in access to biologics and biosimilars.
Advisory Committee Gives Mixed Review to JAK Inhibitor Expected to Challenge Humira
April 24th 2018Yesterday, the FDA’s Arthritis Advisory Committee convened for a vote on whether to recommend approval of Eli Lilly’s baricitinib, a Janus kinase (JAK) inhibitor that the company hopes to sell as Olumiant for the treatment of rheumatoid arthritis (RA). The advisory committee voted in favor of recommending approval of a dose of 2 mg and against recommending approval of a higher 4-mg dose because of concerns about safety, including the risk of thrombosis.
Landmark SCOTUS Ruling Upholds the Inter Partes Review Process
April 24th 2018The Supreme Court of the United States (SCOTUS) ruled today in the case of Oil States Energy Services, LLC, v Greene’s Energy Group, LLC, that the inter partes review process for reviewing patents does not violate the Constitution by adjudicating public rights outside of an Article III court. The Court ruled 7 to 2, with Chief Justice John Roberts and Justice Neil Gorsuch dissenting.
Could Etanercept Hold Promise for Treating Spinal Cord Injuries?
April 23rd 2018After spinal cord injury, oxidative stress, inflammation, and mitochondrial dysfunction can cause neural damage that was once believed to be both immediate and irreversible. However, neuronal death is now believed to proceed over a period of several days after initial trauma, and to include cellular, molecular, and biochemical cascades, including local inflammatory responses. Tumor necrosis factor is believed to be involved in the local production of cytokines at the site of the injury.
Experience With Manufacturing Changes Underscores Importance of Stepwise Approach to Biosimilars
April 19th 2018In the case study, the authors report findings from a comparability assessment of epoetin alfa before and after a proposed manufacturing process change for which, they say, nonclinical assessment of structure-function relationships were not sensitive enough to identify clinically relevant differences resulting from differences in the drug’s glycosylation profile.
Patient Support Programs Associated With Greater Likelihood of Controlled AS
April 17th 2018Canadian patients who receive brand-name adalimumab (Humira) to treat ankylosing spondylitis (AS) are eligible for a patient support program, provided by drug maker AbbVie, that includes personalized services such as coaching phone calls before and after initiating treatment.
ACR Says Final Rule on EHB Benchmark Plans Could Reduce Access to Biologics
April 13th 2018This week, the American College of Rheumatology (ACR) raised concerns that CMS’ final 2019 Payment Notice Rule, which provides states with increased flexibility to determine which plan options they can select as Essential Health Benefit- (EHB) benchmark plans and select their own sets of benefits, could seriously jeopardize care for patients with inflammatory diseases.
Oncologist Sees Biosimilars Playing a Role in the Oncology Care Model
April 12th 2018Kashyap Patel, MD, CEO of Carolina Blood and Cancer Care, told The Center for Biosimilars® in an interview that, as his practice has begun to implement the Oncology Care Model, it has moved 100% of its patients to biosimilar filgrastim, Zarxio, from the reference filgrastim, Neupogen.
Mylan to Partner With Fujifilm Kyowa Kirin Biologics on Adalimumab Biosimilar
April 11th 2018The European Medicines Agency accepted for review a marketing authorization application for the proposed biosimilar, FKB327, in May 2017, and the companies say that they expect to receive the EMA’s decision during the second half of 2018.
Pfizer Execs Underscore the Need for a Level Playing Field for Biosimilars
April 10th 2018In a press briefing today at Pfizer’s headquarters in New York, New York, Pfizer’s executives reviewed their progress with biosimilars to date and underscored the need for a level playing field if biosimilars are to compete with brand-name biologics in the United States.
Misuse of Limited Distribution Networks Prevents Biosimilar Market Entry
April 10th 2018Limited distribution networks, which are established when a drug maker contracts with either 1 or a limited number of distributors, can allow a manufacturer to efficiently manage the supply chain for a given product. However, as a recent paper argues, LDNs can have an anticompetitive impact on the marketplace.
Study Suggests That Two AEs May Predict Improved Outcomes With Bevacizumab
April 9th 2018A recent study concludes that both hypertension and proteinuria, which are considered to be interrelated with the pharmacological action of bevacizumab, have the potential to indicate greater likelihood of therapeutic efficacy.
FDA Releases 5-Year Financial Plan for Biosimilar User Fee Act
April 6th 2018The financial plan, which is revised each year, outlines the financial position of the Biosimilar User Fee Act program over the next 5-year authorization period, and explains how the FDA will allocate resources to build its biosimilars review program.
Samsung Bioepis Settles With AbbVie, Clearing Way for EU Launch of Adalimumab Biosimilar
April 5th 2018Samsung Bioepis and Biogen announced today that the companies have reached a settlement with AbbVie, maker of the top-selling Humira, that will allow the partnership to launch their approved biosimilar—Imraldi—in the European Union on October 16, 2018.
FDA Rejects Celltrion's Rituximab and Trastuzumab Biosimilars
April 5th 2018Today, Celltrion announced that the FDA has issued Complete Response Letters (CRLs) for 2 of its products, CT-P10, a proposed rituximab biosimilar referencing Rituxan, and CT-P6, a proposed trastuzumab biosimilar referencing Herceptin.
NHS Prepares for October 2018 Arrival of Biosimilar Adalimumab
April 4th 2018In a briefing to regional committees, the United Kingdom's National Health Service (NHS) urged commissioners to begin planning to use the best-value adalimumab option beginning in October 2018, when Amgen’s EU-authorized biosimilar, Amgevita, becomes available.
Long-Term Adalimumab Provides Sustained Benefits in Axial Spondyloarthritis
April 3rd 2018A recent study provides the final long-term efficacy and safety results from the phase 3 ABILITY-1 trial’s open-label extension in patients with nonradiographic axial spondyloarthritis, which show that the anti–tumor necrosis factor agent adalimumab (Humira) provided sustained clinical and functional improvements through 3 years.