News

With the likelihood increasing that the United Kingdom will leave the European Union without a trade agreement in early 2019, the UK Health Secretary, Matt Hancock, has issued new advice to the pharmaceutical industry in which he warned that there could be long border delays that seriously impact the flow of pharmaceuticals in Europe.

Samsung Bioepis has announced that a 1-year follow-up study comparing event-free survival in patients treated with SB3, a biosimilar trastuzumab (approved in Europe as Ontruzant) showed that the biosimilar has similar safety and efficacy profiles to the reference Herceptin.

Coherus Biosciences, which recently gained its first biosimilar approval for Udenyca, a pegfilgrastim biosimilar referencing Neulasta, has announced that it has signed a 340B prime vendor program contract with Apexus LLC.

The complaint includes a screenshot of Xanthe Lam’s Genentech-issued computer, which shows a folder titled “JHL” that contained subfolders, 4 of which were named for Genentech medicines for which JHL was in the process of developing a biosimilar.

The Center for Biosimilars® recaps the top news for the week of December 3, 2018.

In the United States, Amgen has 57 patents on Enbrel, whereas in Europe it has 20, and in Japan it has 18.

A slowdown in overall spending was driven, in part, by reduced growth in spending on prescription drugs. In 2014, spending on these drugs grew by 12.4%; this pace saw just 0.4% growth in 2017.

While other stakeholders also need clarification of the FDA policies, it is the developers who will make it possible to bring lower-cost biosimilars to make a real difference. In this paper, I am providing comments on the proposed action plans of the FDA and pointing out what I believe to be the missing elements.

Last month, the European Parliament’s Health Committee introduced amendments to Supplementary Protection Certificate (SPC) manufacturing waivers. On December 4, 2018, the committee voted in favor of the amendments.

In revised draft guidance published in October 2018, the FDA announced its intention to crack down on citizen petitions that seek to delay competition from generic or biosimilar drugs. Now, in a comment letter, the Federal Trade Commission (FTC) has said that it stands ready to work with the FDA on curtailing abusive petitions.

After increased pressure on pharmacy benefit managers to remake their approaches to rebates, CVS Health has announced that it will offer a new prescription benefit option in 2019 that will pass all drug makers' rebates back to its plan clients.

This week, the American College of Rheumatology and the National Psoriasis Foundation released a new treatment guideline for psoriatic arthritis (PsA) that contains evidence-based recommendations on caring for patients with this inflammatory disease.

Celltrion has announced that the European Medicines Agency (EMA) has accepted for review an extension marketing authorization application for a subcutaneous formulation of the company’s biosimilar infliximab, CT-P13 (sold in Europe as Remsima and in the United States as Inflectra).

The Biosimilars Forum is lending its support to Pfizer’s August 2018 citizen petition to the FDA to clarify appropriate sponsor communications about biosimilars.

On Friday, Pfizer announced that it has signed an agreement with AbbVie that resolves all intellectual property disputes related to Pfizer’s PF-06410293, a proposed biosimilar adalimumab referencing Humira.

Earlier this week, Daiichi Sankyo announced that it has launched its biosimilar trastuzumab, trastuzumab BS, referencing Herceptin, in Japan.

The Center for Biosimilars® recaps the top news for the week of November 26, 2018.

During November 2018, biosimilar developers worldwide made tough choices about how to move forward with their products and pipelines.

Earlier this week, Bioprocess International reported that Boehringer Ingelheim (BI) had decided to focus on launching its biosimilar products solely in the US market, and would forego launches in the European Union. The Center for Biosimilars® was able to independently confirm this report in an email with a representative from BI.

JCR Pharmaceuticals announced yesterday that it has launched its biosimilar agalsidase beta product, referencing Fabrazyme, in Japan for the treatment of Fabry disease. JCR developed the drug in partnership with Amicus Therapeutics and GlaxoSmithKline.

A founding member of the Biosimilars Forum has withdrawn its membership from the organization. Amgen has confirmed to The Center for Biosimilars® that it gave up its membership in the group in September of this year.

The FDA has approved Celltrion and Teva’s rituximab biosimilar, Truxima (rituximab-abbs).

This week, the European Parliament’s Health Committee introduced amendments to Supplementary Protection Certificate (SPC) manufacturing waivers.

This month, the Court of Justice of the European Union ruled that Italy’s national health system can reimburse for the use of bevacizumab in the treatment of eye diseases, such as age-related macular degeneration, despite the fact that bevacizumab does not have a marketing authorization for this indication.

The Association of the British Pharmaceutical Industry, a trade group representing UK drug makers, announced that it has reached a voluntary deal with the UK government that involves capping the growth of sales of brand-name drugs to the National Health Service at 2% per year in exchange for faster product launches and speedier appraisals by the National Institute for Clinical Excellence (NICE).

The European Commission, in conjunction with the Organization for Economic Co-operation and Development, has released its Health at a Glance: Europe 2018 report which highlights the need for and value of generic and biosimilar products.

The proposed rule would allow plans to make broader use of prior authorization and step therapy for drugs—including drugs in protected classes—that are covered under Part D.

Sandoz announced today that the European Commission has granted a marketing authorization for its pegfilgrastim biosimilar, Ziextenzo, referencing Neulasta.

Last week, Biosimilars Canada, a trade organization representing Canada’s biosimilar developers including Sandoz, Mylan, and Fresenius Kabi, among others, announced that it had chosen Innomar Strategies to be the preferred provider for the Biosimilars Canada Patient Support Program platform.

This morning, the United Kingdom’s National Health Service (NHS) announced that it has completed negotiations over using the best-value adalimumab product, and it has arrived at a plan whereby it will save £300 million (approximately $386 million) of its current £400 million-per-year (approximately $514 million) spending on adalimumab.