News

Alexion Pharmaceuticals’ brand-name eculizumab (Soliris) gained its fourth approval, this time for the treatment of neuromyelitis optica spectrum disorder (NMOSD).

The FDA today announced a proposed rule that would amend regulations concerning the use of master files for biologics. According to the FDA, this rule is necessary to avoid any disruption to products that will transition from regulation as drugs to regulation as biologics in 2020.

Eli Lilly and Company, together with partner Innovent Biologics, announced today that China’s National Medical Products Administration will review its application for IBI301, a proposed rituximab biosimilar referencing MabThera and Rituxan.

The Biosimilars Council, a part of the Association for Accessible Medicines, has issued a new white paper in which it condemns abuses of the patent system that delay biosimilar competition. It also argues that legislative proposals to regulate settlements would “merely benefit companies investing in the creation of patent thickets.”

The US biosimilars market is really taking off, with 4 biosimilar products launched in the past year and 7 biosimilar products (Zarxio, Inflectra, Renflexis, Fulphila, Nivestym, Retacrit, and Udenyca) in total on the market, competing with 4 originator medicines. The projected annual savings to the US healthcare system could climb to $60 billion in 2023 for a 5-year total of $153 billion. Those projections come from the IQVIA Institute for Human Data Science, which also projects a near doubling of biosimilar product competition in the US biologics marketplace by 2023.

Data from switching studies will bolster another important facet of the biosimilars marketplace: patient and prescriber confidence. In a marketplace in which patients move from one formulary to another, from one year to the next in their journey with chronic illnesses, it will be helpful to know that interchangeable biosimilars offer equal safety and efficacy after multiple switches.

Amgen, Eli Lilly, and Merck, together with the Association of National Advertisers, have filed a lawsuit against HHS and CMS over the Trump administration’s rule requiring disclosure of list prices for drugs in direct-to-consumer television advertisements.

In this case, Pfizer hoped to launch its biosimilar bevacizumab in the UK market after the basic patent on the reference product, Genentech and Roche’s Avastin, expires in June 2020. However, the biosimilar maker has been hindered by what it has termed a patent thicket related to secondary patents.

Drug maker AbbVie today announced that it has reached a $63 billion transaction agreement under which it will acquire Allergan.

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.