Kelly Davio

The FDA has issued new draft guidance on how biologic product sponsors should address postapproval changes in chemistry, manufacturing, and controls.

This week, the FDA released a Form 483 noting observations made when inspecting Celltrion’s manufacturing facility in May and June 2017. The heavily redacted form notes 12 observations.

The FDA’s Adverse Event Reporting System, which allows healthcare professionals, patients, and others to submit reports on adverse events, contains over 8.5 million entries, a massive number complicated by the fact that any drug may be listed under an average of 16 different names.

Seth D. Ginsberg, co-founder of Global Healthy Living Foundation, told The Center for Biosimilars®, “Currently the benefit of rebating and pricing of all infused drugs goes to the payers, health systems, hospitals and physicians, not the patients. Until patients participate in such savings, infused drug pricing has nothing to do with them.”

USV, a Mumbai-based pharmaceutical company, announced on Thursday that it had successfully completed phase 1 and phase 3 studies on a proposed pegfilgrastim biosimilar referenced on Neulasta. The company expects to submit data for its marketing authorization application to the European Medicines Agency before the end of 2017.

The FDA has granted tentative approval of Sanofi’s follow-on insulin lispro injection, Admelog. Referenced on the originator product, Humalog, Sanofi’s insulin lispro is a rapid-acting human insulin analog indicated to improve glycemic control in adults and children with diabetes.

This week, FDA commissioner Scott Gottlieb, MD, announced that the agency’s Center for Drug Evaluation and Research (CDER) and the Office of Regulatory Affairs (ORA) are implementing a new agreement to integrate drug review programs with facility evaluations and inspections.

A recent paper published in the World Journal of Gastroenterology examines the complexities posed by biologics and biosimilars in the transition care of adolescent patients who have inflammatory bowel disease (IBD).

Biocon announced today in a letter to the National Stock Exchange of India that the FDA has extended its target action date for a regulatory decision on the drug maker’s trastuzumab biosimilar.

A recently published study found that the auto-injector device used to deliver a biosimilar etanercept was preferable to the auto-injector device used to deliver reference etanercept (Enbrel) among patients with rheumatoid arthritis and healthcare providers who treat patients with RA.

August saw notable developments in the market for insulins in the world of endocrinology biosimilars and follow-ons: new studies showed similarity between a challenger to branded insulin glargine; price competition gained momentum; and patients, providers, and state governments signaled an urgent need for diabetes drug prices to drop.

Roche’s sales of ranibizumab (Lucentis), already depleted by competition from such products as afilbercept (Eylea), face upcoming erosion from biosimilar competition.

Samsung Bioepis, a joint venture between Samsung Biologics and Biogen, announced that it has received the European Commission’s (EC) approval for its adalimumab biosimilar (Imraldi), referenced on AbbVie’s blockbuster Humira.

The FDA has signed a new confidentiality agreement with the European Commission (EC) and the European Medicines Agency (EMA). The agreement will allow the FDA to share with the EC and EMA nonpublic, commercially confidential information (including trade secrets) related to inspections.

A study published in the British Journal of Clinical Pharmacology demonstrated the bioequivalence of GP2015, a biosimilar etanercept treatment (Sandoz’s Erelzi), when delivered with an auto-injector and when delivered with pre-filled syringe in patients across a variety of body weights.

Drug maker Alexion has announced 3 new US patents for its eculizumab (Soliris), a first-in-class monoclonal antibody that specifically binds to the complement protein C5. Additionally, the drug gained the European Commission’s approval for the treatment of refractory generalized myasthenia gravis.

Febrile neutropenia (FN) is among the most common complications of chemotherapy, and a recent post-marketing, multi-center, real-world, non-interventional, epidemiological study sought to examine the use, safety, and efficacy of biosimilar filgrastim in the primary and secondary prevention of FN.

A recent paper, published in BioDrugs, argues that, in biosimilar development, bridging studies between locally licensed and internationally licensed reference biologics may be unnecessary.

Yesterday, Biocon withdrew from the European Medicines Agency (EMA) its applications for the authorization of biosimilar trastuzumab and pegfilgrastim.

While the FDA appears to be taking a more active role in leveraging its position to influence drug prices, the majority of efforts to bring down pharmaceutical costs are taking place at the state level.

The European Medicines Agency announced this month that it has initiated a business continuity plan to cope with the political uncertainty and the workload implications of the United Kingdom’s impending withdrawal from the European Union.

Ireland’s Minister for Health has published a consultation paper on overhauling the nation’s approach to biosimilar medicines. The paper indicates that the Irish government is developing a National Biosimilar Medicines Policy “to promote the rational use of biosimilar medicines and to create a sustainable environment for biological medicines in Ireland.”

Price competition in the US insulin market is heating up; Novo Nordisk reported in its second-quarter earnings call that its 2018 US insulin prices could drop below 2017 levels.

Insurers operating in the Affordable Care Act marketplace face fresh uncertainties as they plan for 2018: whether Congress will continue in its efforts to repeal or replace the ACA, whether the Trump administration will enforce the individual mandate, or even whether the federal government will continue to pay insurers for cost-sharing reductions are all unanswered questions.

A recently published study demonstrates that sarilumab improves patient-reported outcomes in patients with rheumatoid arthritis who did not achieve adequate response with, or who were intolerant to, anti-tumor necrosis factor (anti-TNF) agents.

Coherus 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.

Kyle 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.

The 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.

New 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).

The FDA’s Arthritis Advisory Committee (AAC) did not recommend the approval of Janssen Biotech’s sirukumab, a proposed monoclonal antibody for the treatment of moderate to severe rheumatoid arthritis, over concerns about mortality.