Coherus Petitions for IPR of Key Etanercept Patent
August 9th 2017Coherus BioSciences announced this week that it has filed a petition for inter partes review of a key patent protecting Amgen’s etanercept (Enbrel). Patent 8,163,522 (also known as the ‘522 patent) concerns a process for isolating non-soluble proteins.
Pharmacist Sees Cost, Programs, Safety as Key Payer and Provider Concerns With Biosimilars
August 8th 2017Kyle F. Skiermont, PharmD, COO of Fairview Pharmacy Services, spoke with The Center for Biosimilars® about his experience with payers and providers as they prepare for the impact of biosimilar drugs and possible non-medical switching.
Anti-TNF Agents Improve Outcomes, Raise Risks in East Asian Patients With IBD
August 8th 2017The introduction of anti-tumor necrosis factor-alpha agents has improved treatment options for patients with inflammatory bowel disease. However, these agents can also lead to increased vulnerability to infections, development of autoimmune diseases, malignancies, and decreased immunogenicity of vaccinations.
FDA Inspection Notes 10 Problems With Biocon's Manufacturing Facility
August 8th 2017The FDA’s Office of Surveillance has released its findings from an inspection of Biocon’s troubled manufacturing facility in Bangalore, India. The agency listed 10 observations made during the agency’s inspection conducted during May and June of 2017.
Some Consumers Must Buy Brand Name Drugs, Not Generics
August 8th 2017Contradicting standard advice given to most patients that the preferred medication is a less-expensive generic medication, rather than a brand-name drug, some health insurers are telling consumers the opposite: they must buy brand-name drugs even when cheaper generics are available.
Eye on Pharma: Regeneron and Sanofi Terminate Antibody Discovery Agreement
August 8th 2017New York-based Regeneron has announced that it will allow one of its key partnerships with the French drug maker Sanofi to terminate at the end of the year without an extension. The companies’ Antibody Discovery Agreement was responsible for the discovery and development of such drugs as alirocumab (Praluent), dupilumab (Dupixent), and sarilumab (Kevzara).
Review Highlights Lessons Learned from 4 Biosimilar Approvals
August 7th 2017The FDA’s biosimilar pathway has encouraged a robust product pipeline, but the fact that few biosimilar drugs have been approved by the agency thus far means that there is still some industry uncertainty on the FDA’s approach to this class of products.
AbbVie Files Complaint Against BI in New BPCIA Litigation Over Humira
August 5th 2017AbbVie is engaged in new litigation over its blockbuster adalimumab (Humira). This week, the drug maker filed suit against Boehringer Ingelheim in a Delaware federal court, saying that BI will infringe on 74 of its patents for adalimumab in its development of a biosimilar product, BI 695501.
Developing the Totality of Evidence for Biosimilarity
August 4th 2017The development of biosimilars is focused on the minimization of potential differences between the proposed biosimilar and reference product, as well as the establishment of a robust manufacturing process to consistently produce a high-quality biosimilar.
Amjevita Similar to Humira in Efficacy, Safety, and Immunogenicity in RA
August 3rd 2017A recently published study shows that Amgen’s ABP 501 (Amjevita), referenced on Humira, shows that the product has similar efficacy, safety, and immunogenicity to its reference in patients with moderate to severe rheumatoid arthritis.
Biosimilars Lead to Lower Q2 Sales for Sanofi, Muted Success for Pfizer
August 2nd 2017Sanofi’s 2017 second-quarter sales from its diabetes and cardiovascular business declined by 15% relative to the same sales quarter last year, the French drug maker reported on Monday. Sanofi cited biosimilar competition in Europe as well as exclusion from US formularies as the chief reasons for its steep sales decline.
French Clinicians' Use of Zarzio for Neutropenia Risk Driven by Patient Factors
August 2nd 2017Data from a recent study show that biosimilar filgrastim is readily used in France for the prophylaxis of chemotherapy-induced neutropenia. The data also demonstrate that clinicians’ assessment of febrile neutropenia risk is driven by patient factors more than by the European Organisation for the Research and Treatment of Cancer’s risk category of the chemotherapy regimen.
Demand-Side Policies Increase Biosimilar Market Penetration in Europe
August 1st 2017An examination of national policies on biosimilars in 10 European Union member states concludes that supply-side policies targeting price can limit biosimilar penetration in the long term, while demand-side policies positively impact biosimilar uptake and are important drivers for biosimilar market penetration.
FDARA May Be Delayed, But So Are FDA Layoffs
July 31st 2017The Senate may not consider the FDA Reauthorization Act (FDARA) until early September, after the congressional recess. The delay comes after Senator John McCain (R-Arizona) returned to the capitol to vote in favor of advancing a debate over healthcare reform.
A Look at the Regulatory Process for Approval of Biosimilar Insulins in Europe
July 29th 2017The emergence of biosimilar insulins may help broaden access to modern insulins, increase individualized treatment options, and reduce the cost of insulin therapy. Yet many healthcare providers may not understand the concept of biosimilarity and how biosimilar medications are similar, not identical, to their reference products.