News

Recently, researchers reported 72-week results from a phase 3 trial of biosimilar rituximab, CT-P10 (Truxima), in patients with rheumatoid arthritis (RA), in which they concluded that the product was well tolerated in long-term use and that switching from the reference did not yield differences in safety, efficacy, pharmacodynamics, or immunogenicity.

No statistically significant risk in terms of lack of effectiveness or safety was found for patients who switched therapies versus those who remained on their first therapy in either the reference group or the biosimilar group.

China-based drug maker Henlius has announced that the European Medicines Agency (EMA) has accepted for review the company’s marketing authorization application for a trastuzumab biosimilar, HLX02, referencing Herceptin.

Drug maker Alexion, developer of the rare disease drug eculizumab (Soliris), announced Friday that the FDA has accepted for priority review its long-acting C5 complement inhibitor, ravulizumab (Ultomiris), which offers less frequent administration than eculizumab.

Slow uptake of biosimilars, among other factors, will help propel drug spending over the next 7 years, according to a report released this week by PwC’s Health Research Institute (HRI).

The attributes for the N-glycan profile, FcγRIIIa binding activity, and relative antibody-dependent cell-mediated cytotoxicity (ADCC) activity for the reference trastuzumab resulted in reduced ADCC and FcγRIIIa binding activities.

The Center for Biosimilars® recaps the top stories for the week of June 17, 2019.

Legislators on Capitol Hill are moving forward this month with bills that address patent issues pertaining to biosimilars.

According to the authors of a new study, while biologics are often believed to be more time consuming to develop than small-molecule drugs, development times are, in fact, similar between these 2 drug types.

A worldwide survey conducted by an international type 1 diabetes (T1D) advocacy non-profit found that rationing of insulin and related supplies was the greatest in the Unites States.

Biocon’s biologics facilities in Bengaluru, India, have received an EU certification of good manufacturing practice (GMP) after a March 2019 inspection, said the drug maker last week in a notice to the National Stock Exchange of India.

A Canadian advisory council is recommending the use of biosimilars in a final report that lays out 60 recommendations for how the country can create a C$15.3 billion universal, single-payer, public system for pharmaceutical coverage.

Irish hospitals will be offered a €500 (US $561) incentive for each patient switched from brand-name Humira or Enbrel to a biosimilar option.

Given the cost of the brand-name drug, there is interest among providers, particularly in contexts with limited resources, in using a biosimilar rituximab to treat pemphigus, and recently, 2 studies reported on the use of biosimilar rituximab in treating this disease.

Researchers say they were able to create an “antibody lock” that makes infliximab more selective in its activity, making it safer and more effective.

The Center for Biosimilars® recaps the top stories for the week of June 10, 2019.

Kanjinti was approved for the treatment of HER2-positive breast cancer and gastric cancer.

The introduction of infliximab for the treatment of inflammatory bowel diseases (IBD) did not result in lower population rates of hospitalizations or intestinal surgeries among patients living with IBD in Ontario, Canada, according to a study published Thursday.

Drug maker Genentech, developer of the brand-name rituximab, Rituxan, has announced that the FDA has accepted a supplemental Biologics License Application for the drug’s first proposed pediatric indication: 2 rare forms of vasculitis.

A new consensus paper from the Asia-Pacific Working Group on inflammatory bowel disease (IBD) released a set of best practices for improving IBD care with biologics and biosimilars.

The American Medical Association (AMA), which is holding its annual meeting this week in Chicago, Illinois, has issued a call for intensified oversight of the pharmacy benefit manager (PBM) industry.

“Do I think these numbers are reasonable and achievable? Potentially,” said Christina Corridon, MPH, MBA, a principal with the consulting firm ZS.

This month, a research letter appearing in JAMA Internal Medicine raises the questions of whether regulatory filings for new products are already made publicly available despite the FDA’s stance of treating these applications as confidential and whether there is room for increased transparency from the agency.

The 2 companies say that they will focus on biosimilars of originator products that will face patent expiry in 2025 to 2030.

A consensus statement developed by the Pan American League of Associations for Rheumatology (PANLAR) regarding biosimilars warned against the use of so-called "biomimics," or copy biologics.

“This systematic literature review found that the overall economic impact of biosimilar [nonmedical switching] remains uncertain,” write the investigators. More real-world studies will be necessary, they indicate, to quantify the full economic impact of nonmedical switches over the short and long term.

Insulin maker Sanofi is currently developing a proposed biosimilar of insulin aspart (NovoLog), made by Novo Nordisk. In 3 late-breaking poster presentations at the American Diabetes Association (ADA) 79th Scientific Sessions, held June 7-11, 2019, in San Francisco, California, researchers presented data on the biosimilar, SAR341402.

Pfenex and its partner Alvogen have submitted to the European Medicines Agency (EMA) a Marketing Authorization Application for PF708, which is a proposed biosimilar of teriparatide (Forteo), an osteoporosis drug.

A bill supported by a coalition of physician specialty organizations was introduced in the House of Representatives this week to alleviate the growing use of prior authorizations in Medicare Advantage. At the same time, the group released survey results saying that PAs are increasing physician burdens and leading to delays in patient care.

Early treatment with a biosimilar agent increased total costs by £70 (US $89) per patient versus standard intervention.