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

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.”

A panel at the ACI 10th Summit on Biosimilars focused on the recent FDA decision around the naming of biosimilar products and what that means for the industry, as well as related issues.

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.

The first set of presentations on day 2 of the ACI 10th Summit on Biosimilars on Tuesday in New York City reviewed the economics of biosimilar drugs and considerations for access, pricing, and reimbursement.

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

Under which situations might the International Trade Commission (ITC) be the right choice for biosimilar patent disputes instead of federal district court? A panel discussed these questions at the ACI 10th Summit on Biosimilars on Monday in New York City.

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

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.

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

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.

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

“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.

This week on the podcast, we're speaking with regulatory attorney James Shehan, JD, chair of regulatory practice at Lowenstein Sandler, LLP. In a prior role, Shehan had a hand in crafting the language that became the Biologics Price Competition and Innovation Act, which set forth the legal standard for interchangeability. Shehan discusses what the newly released guidance means for developers, what he thinks about the upcoming transition of insulins to regulation as biologics, and his view on the potential for interchangeable insulin biosimilars.

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.

The Center for Biosimilars® recaps the top stories for the week of June 3, 2019.

Competition has done little to keep the lid on rising pharmaceutical prices for brand-name products, especially insulins and anti-inflammatory drugs, and costs will continue to rise unless action is taken, according to a recent paper written by researchers from the Scripps Research Translational Institute.

Generic drug maker Lannett Company has announced the beginning of a clinical trial of its proposed biosimilar insulin glargine referencing Lantus.

Last year, when noted researcher James Allison, PhD, won the Nobel Prize for Physiology or Medicine for his pioneering work that led to the development of groundbreaking oncology treatment, he took the occasion as an opportunity to decry what he said was a death of basic scientific research, as development for new pharmaceuticals is usually tied to closely guarded company data.

Ahead of the anticipated 2019 marketing of FDA-approved anticancer biosimilars in the United States, pharmacy benefit manager (PBM) Magellan Rx Management today announced the launch of an oncology biosimilar program.

Prestige BioPharma announced this week that the European Medicines Agency (EMA) has accepted for review its Marketing Authorization Application for a proposed trastuzumab biosimilar, HD201. Prestige hopes to eventually sell the product under the name Tuznue.

The Center for Biosimilars® recaps the top news for the week of May 27, 2019.

The House of Representatives has passed HR 965, the Creating and Restoring Equal Access to Equivalent Samples Act of 2019 (CREATES Act), as well as 2 other bills dealing with drug prices: HR 1499, the Protecting Consumer Access to Generic Drugs Act of 2019, and HR 938, the Bringing Low-cost Options and Competition While Keeping Incentives for New Generics (BLOCKING) Act of 2019.

In its May 2019 network bulletin, UnitedHealthcare announced that, as of July 1, it will prefer the use of brand-name pegfilgrastim, Amgen’s Neulasta, over biosimilar options.

Key biopharmaceutical markets outside the United States are focusing on drug prices, and the increased use of biosimilars is a key part of their strategy, according to a report from the PwC Health Research Institute.

A new Federal Trade Commission (FTC) staff report has found that, despite an increase in patent settlements concerning generic drugs, fewer settlements included the kinds of “pay-for-delay” provisions that are likely to be anticompetitive in nature.