News

The 9 top-selling drugs of 2016 include numerous biologics. Learn what these drugs earned, and how biosimilars are impacting their global sales.

This week, James Stevenson, PharmD, FASHP, professor at the University of Michigan College of Pharmacy, delivered a webinar via the Academy of Managed Care Pharmacy.

The UK government sought to reassure citizens this week that “Brexit,” or the United Kingdom’s withdrawal from the European Union (EU)—and therefore its withdrawal from the European Medicines Agency (EMA)—would not negatively impact patient access to pharmaceuticals.

Samsung Bioepis is reportedly undertaking shorter clinical trials in order to gain faster biosimilar approvals as the company seeks to compete with rival developers and to realize its first annual profits.

Biopharmaceutical medicines represent a growing share of the global pharmaceutical market, with $228 billion in global sales in 2016. As many of these products face the loss of patent protection, biosimilar versions of these molecules may now enter the market, causing a shift in market share and driving changes in pharmaceutical companies’ strategies.

The Center for Biosimilars recaps the top 5 stories in biosimilar news for the week of July 3, 2017.

The expectation of achieving potentially significant health-system cost savings stemming from competition among an increasing number of available biosimilars has led to widespread interest in developing modeling techniques that can accurately estimate the economic impact of biosimilar adoption.

A bipartisan bill, introduced by US Senators Chris Coons (D-Delaware), Tom Cotton (R-Arkansas) Dick Durbin (D-Illinois), and Mazie Hirono (D-Hawaii), seeks to make a number of reforms that would make it easier for innovators—including the manufacturers of reference biologics—to defend against challenges to their patents.

A recent study, published in Transfusion, analyzed 3 granulocyte-colony-stimulating factor treatments in an attempt to compare the mobilization efficiency of 2 innovator G-CSF treatments with that of 1 biosimilar treatment.

A survey and drug utilization analysis conducted among UK healthcare professionals found that 75% of respondents were aware that biosimilars were available on their local formularies, and 77% considered biosimilars to be either extremely or very important to save costs for the National Health Service.

To date, only limited data have been available concerning long-term clinical outcomes of switching patients with inflammatory bowel disease (IBD) from reference infliximab (Remicade) to a biosimilar treatment. A new study concludes that a switch to CT-P13 from reference infliximab was both safe and feasible.

In the wake of Coherus’ 30% reduction in workforce last week—a move that followed the company’s complete response letter from the FDA regarding its CHS-1701, a pegfilgrastim biosimilar candidate—the California-based biosimilar developer has sustained yet another blow to its business.

An FDA official has said that the agency expects interchangeable biosimilars to come to market within 2 years and that the first interchangeable biosimilar will likely be reviewed by an FDA advisory committee of outside experts.

Pegaspargase (marketed as Oncaspar), a biologic drug approved by the FDA in 2006 for acute lymphoblastic leukemia (ALL) as a component of multi-agent chemotherapy, has long gone unchallenged by biosimilar candidates. That could soon change, according to information recently reported by the Generics and Biosimilars Initiative (GaBI).

CT-P6, a proposed biosimilar of trastuzumab, showed equivalent efficacy to reference trastuzumab (Herceptin) as a neoadjuvant treatment in human epidermal growth factor receptor 2-positive (HER2-positive) early breast cancer, according to a recent phase 3 equivalence trial.

Just 2 weeks after Coherus BioSciences announced that it had received a complete response letter (CRL) from the FDA in response to its biologics license application for a pegfilgrastim biosimilar candidate, the company has laid off 51 employees, or approximately 30% of its workforce, in a bid to cut its operating costs by $10 million.

As of July, 2017, 33 US states and Puetro Rico have enacted laws concerning biosimilar substitution.

The Biosimilar User Fee Act of 2012, which authorized the FDA to collect fees from biosimilar drug manufacturers to expedite their applications, is due to expire at the end of September.

The 52 comments the FDA received during the public commentary period on the agency’s January 2017 draft guidance, Considerations in Demonstrating Interchangeability With a Reference Product, included statements from physicians concerned about the proposed policy.

The United Kingdom's National Institute for Health and Care Excellence (NICE), which provides value guidance to the National Health Service, has published its final appraisal determination for baricitinib (Olumiant), a Janus kinase inhibitor, recommending use of the drug as an option for treating severe active rheumatoid arthritis.

The Center for Biosimilars recaps the top 5 stories in biosimilar news for the week of June 26, 2017.

Available data from comparative clinical trials and observational studies strongly confirm the equivalence between CT-P13 and originator infliximab for the treatment of rheumatologic diseases.

Celltrion and Teva announced today that the FDA has accepted the companies’ Biologics License Application (BLA) for CT-P10, a proposed rituximab biosimilar. FDA regulatory action is expected in early 2018.

On June 28, Elaine Blais and Willy Jay, partners at Goodwin Proctor LLP, held a webinar discussing the Supreme Court’s Decision in the case of Sandoz v Amgen. While the court provided some much-needed clarity surrounding requirements of the Biologics Price Competition and Innovation Act “patent dance,” as Blais and Jay pointed out, the court’s ruling left a number of important questions unresolved.

Even as the industry awaited news of the Supreme Court’s ruling in the case of Sandoz v Amgen, many legal experts at the 8th Annual Summit on Biosimilars earlier this month were focused on inter partes review as an alternative to patent litigation under the contentious Biologics Price Competition and Innovation Act.

July 13, 2017, is the day for the review of FDA’s Oncology Drug Advisory Committee (ODAC) will review biologics license applications for biosimilars to trastuzumab (Herceptin) and bevacizumab (Avastin).

State lawmakers are pushing legislation to advance automatic biosimilar substitution at a rapid pace across the nation—33 states and Puerto Rico have already taken action, and 8 more states have bills pending, according to Stephanie Hoops, a market analyst at Decision Resources Group.

The Senate Republicans’ bill to repeal and replace the Affordable Care Act would result in the loss of health insurance for 22 million Americans in 2026 relative to the number who would be insured under current law, according to the nonpartisan Congressional Budget Office’s report.

Today, Sanofi and Regeneron announced that the European Commission has granted marketing authorization for the companies’ sarilumab (Kevzara), which is approved to treat severely active rheumatoid arthritis, and which outperformed Humira in a phase 3 trial.

Sandoz announced today that is has received approval from the European Commission for its biosimilar etanercept (which will be marketed as Erelzi) for the treatment of multiple inflammatory diseases, including rheumatoid arthritis, axial spondyloarthritis, psoriasis, and psoriatic arthritis.