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The United Kingdom’s Members of Parliament voted 305 to 301 to approve an amendment to the Trade Bill that will require the nation’s negotiators to try to secure UK involvement in the European Medicines Agency (EMA) after Brexit.

Xbrane Biopharma and STADA have announced that they have entered into a collaboration agreement for the development of a ranibizumab biosimilar, referencing Lucentis, which will prospectively be sold as Xlucane, in the US, European, and other markets.

The FDA has approved Pfizer's filgrastim-aafi, a filgrastim biosimilar to Amgen's Neupogen. The product, the second filgrastim biosimilar approved in the United States, will be sold under the brand name Nivestym.

After the release of the FDA’s Biosimilar Action Plan this week, many industry stakeholders have spoken out on the actions being taken by the FDA to further competition and increase biosimilar uptake.

Catch up on the week’s top policy, clinical, business, regulatory, legal, and international news from the world of biosimilars.

This week, the Trump administration made a pair of significant policy advancements related to its ongoing efforts to reduce the price of drugs for American patients.

In its comments, the American College of Rheumatology (ACR) stressed that safe and effective treatments should be accessible to all patients at the lowest cost possible, and this mindset should be the fundamental basis for any drug-pricing policy.

The industry group representing generic and biosimilar manufacturers has issued a new report that claims that Ireland’s policies are keeping the nation from benefitting from €25 million (approximately $29 million) in annual savings to its national health system.

In a recent study, only 44.5% of patients with psoriatic arthritis (PsA) persisted with their index biologic for 12 months or more.

During a speech given today in Washington, DC, FDA Commissioner Scott Gottlieb, MD, announced the release of the long-awaited Biosimilar Action Plan.

The FDA has finalized its guidance on labeling of biosimilar products, and FDA Commissioner Scott Gottlieb, MD, called the finalized guidance "one of a suite of deliverables" that will be unveiled as part of the Biosimilars Action Plan.

At the American Diabetes Association’s 78th Scientific Sessions, researchers presented ways in which education—for both patients and providers—can help improve the care of patients with diabetes who use biosimilar or follow-on insulins.

“This is a crucial moment for the growth of biosimilars in the United States, and we are encouraged that HHS is committed to pursuing policies that reward innovation and support provider and patient access and choice,” said Juliana M. Reed, president of the Biosimilars Forum.

Under the agreement, AbbVie will grant Mylan a nonexclusive license to sell its drug in the United States and in other markets outside of Europe. The US license term for the biosimilar will start on July 31, 2023, and Mylan will pay royalties on its sales to AbbVie.

In an email to The Center for Biosimilars®, Mylan confirmed that it will launch its biosimilar pegfilgrastim at a wholesale acquisition cost (WAC) of $4175 per syringe, a price that reflects a 33% discount to the WAC of Amgen’s reference product, Neulasta.

A Pfizer manufacturing site for injectable drugs, Hospira Healthcare in Tamil Nadu, India, has received a 32-page Form 483 from the FDA.

Biosimilars of anticancer monoclonal antibodies are emerging in the therapeutic landscape, and while the body of evidence concerning switching to supportive care biosimilars—epoetin and filgrastim biosimilars—is robust, there are fewer data available concerning a switch to biosimilars of products such as rituximab, trastuzumab, and bevacizumab.

In India, Razumab, manufactured by Intas Pharmaceuticals, was approved as a similar biologic to ranibizumab in 2015; the retrospective study RE-ENACT collected data and analyzed the effectiveness of this biosimilar product in the real-world setting in patients with age-related macular degeneration, diabetic macular edema, and retinal vein occlusion (RVO).

This week, JHL Biotech announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has granted ithe company a positive Scientific Advice to begin a phase 3 clinical trial of its potential rituximab biosimilar, JHL1101.

Vermont and Connecticut have recently signed laws providing a pathway for and regulations around the substitution of interchangeable biosimilars for the reference biologic product at the pharmacy level.

Transitioning from reference adalimumab (Humira) to Amgen’s FDA- and EU-approved adalimumab biosimilar ABP 501 (Amgevita) was not associated with increased immunogenicity over an observation period of 72 weeks in patients with rheumatoid arthritis, according to the results of a study presented at the European Congress of Rheumatology.

The Center for Biosimilars® recaps the top 5 articles for the week of July 9, 2018.

Earlier this month, US Senators Chuck Grassley, R-Iowa, and Amy Klobuchar, D-Minnesota, sent a letter to Federal Trade Commission (FTC) Chairman Joseph Simons urging the FTC to “examine whether makers of biologic medicines are using strategies like ‘pay-for-delay’ to hinder or delay biosimilars from entering the market.”

Prestige BioPharma and Alvogen have recently announced that they have entered into an exclusive partnership for the commercialization of Prestige BioPharma’s trastuzumab biosimilarin Central and Eastern Europe.

Amgen recently announced top-line results from a phase 3 clinical trial that sought to evaluate the safety and efficacy of its proposed infliximab biosimilar, ABP 710, compared with the reference product (Remicade) in patients with moderate-to-severe rheumatoid arthritis (RA).

Italian researchers report that 72% of their trial participants being treated for psoriatic arthritis achieved sustained remission with ETN 25 mg biweekly, which was maintained a year after treatment initiation.

Lupin recently announced that it has entered into a partnership agreement with Mylan to commercialize its proposed etanercept (Enbrel) biosimilar.

The FDA recently released a draft guidance document that provided an overview of the content and format of information sponsors should include in the “Indications and Usage” section of a drug label for drugs and biologics.

Despite progress in the successful treatment of patients with rheumatoid arthritis (RA) who are using conventional synthetic disease modifying anti-rheumatic drugs (csDMARDs) and biological DMARDs (bDMARDs), a Greek study has found that a considerable number of patients are still not achieving low disease activity (LDA) despite having been treated following established recommendations for RA therapy.

Last week, the FDA issued a 32-page Form 483 to Mylan after a 5-week inspection of its manufacturing plant in Morgantown, West Virginia. The FDA cited 13 inspection observations, including failure to follow proper quality control protocols, lack of adequate cleaning of utensils and equipment, and ineffective laboratory controls and sampling, among others.