Jackie Syrop

The prospective adalimumab biosimilar CinnoRA was shown in a recently published phase 3 trial to be comparable to AbbVie’s innovator biological treatment Humira in terms of safety and efficacy in adult patients with active rheumatoid arthritis.

A new survey assessing awareness of and attitudes about biosimilars among medical specialists and pharmacists in Ireland found that majority of such experts say that they are familiar or very familiar with the term “biosimilar,” but many general practitioners (GPs) were either unable to define or had never heard the term.

An analysis of 53 switching studies reveals a variable level of good-quality evidence regarding switching from reference drugs to their biosimilars.

The cost of developing copy versions of complex drugs—biosimilars and follow-ons for biologics and copies of nonbiological complex drugs such as nanomedicines, including drug-carrying liposomes—can be decreased, according to a new white paper.

Primary results from the ASSIST-FL Phase 3 clinical trial of GP2013, a proposed biosimilar of reference rituximab (Roche’s Rituxan, MabThera), showed that GP2013 is a viable rituximab biosimilar candidate for patients with previously untreated advanced follicular lymphoma.

A study published in the Journal of Clinical Pharmacy and Therapeutics found that SB5, a proposed biosimilar to AbbVie’s Humira, had pharmacokinetic (PK) equivalence to both European-sourced and US-sourced adalimumab.

To gain an understanding of how stakeholders use or consult medicinal product information and to investigate their preferences for the content of biosimilar labels, a multi-stakeholder workshop was held in Brussels, Belgium.

Treating patients with biosimilars of expensive biologic medications has the potential to reduce the costs of treatment for patients and payers, but the use of biosimilars has not translated into savings for most providers, which limits broader adoption of biosimilars, according to a recent analysis.

Spherix Global Insights’ recently released survey of 103 US gastroenterologists reveals that practitioners project significant growth in the use vedolizumab, golimumab, and Pfizer’s Inflectra, an infliximab biosimilar, for the treatment of ulcerative colitis over the next 6 months.

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 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 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.

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.

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.

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.

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.

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.

Biologic medications are an integral, crucial, and effective part of medical management for many life-threatening diseases and conditions, including cancer. As a recent position paper by the European Society for Medical Oncology (ESMO) points out, the anticancer market is expected to pass the €140 billion (apx. $157 billion) by 2020.

The FDA rejected, for a second time, Pfizer’s application for approval of its biosimilar epoetin alfa (Epoetin Hospira), a colony-stimulating factor indicated for anemia, biosimilar to Epogen and Procrit.

FDA Commissioner Scott Gottlieb, MD, has unveiled a new plan to facilitate increased competition in the prescription drug market through approval of more lower-cost, generic medications.

Spanish researchers recently reported reliable detection of antibodies to infliximab (ATI) from venous or capillary blood using a rapid, point-of-care (POC) ATI test that allowed clinicians to detect ATI in a quick, decentralized mode that facilitated immediate POC decision making.

Pharmaceutical manufacturers, pharmacy benefit managers, and various trade groups respond to the recent Supreme Court decision on the 6-month marketing rule post FDA approval for biosimilars.

Republican Nevada Governor Brian Sandoval yesterday signed into law the country’s strictest requirements for drug companies to show how they set prices for certain prescription drugs, with a specific focus on insulin.

States have taken the lead in advancing strategic policies and programs to attract, retain, and grow an innovative biopharmaceutical presence in the United States, according to a new report conducted for the Pharmaceutical Research and Manufacturers of America (PhRMA), which represents leading US biopharmaceutical research companies.

The study pesented at the American Diabetes Association 77th Scientific Sessions compared Mylan/Biocon’s MYL-1501D, a proposed biosimilar to Sanofi-Aventis’ insulin glargine, with the reference product.

Two new reports of clinical switching studies in which patients undergoing treatment for rheumatoid arthritis (RA) were switched to a biosimilar version of the respective drugs provide some reassurance about the safety and efficacy of biosimilar products for infliximab (Remicade).

The Institute for Clinical and Economic Review (ICER) has issued a report recommending that dupilumab (Dupixent) offers good long-term value and important clinical benefit for patients with moderate-to-severe atopic dermatitis.

The US biopharmaceutical industry faces mounting global competition from countries in the developing world and Europe that are increasingly implementing pro-innovation programs and strategies in the sector, according to a new report conducted for the Pharmaceutical Research and Manufacturers of America (PhRMA)

FDA Commissioner Scott Gottlieb, MD, said that the agency is examining how to push drug applications to “the front of the line” when there are fewer than 3 competing manufacturers for generic versions of a particular medication.