The Center for Biosimilars Staff

Drug maker Amgen announced this week that it has submitted a Biologics License Application (BLA) for ABP 710, a proposed infliximab biosimilar referencing Remicade.

Australian drug developer NeuClone has disclosed that it is currently developing a proposed pertuzumab biosimilar referencing Perjeta.

In its annual preview of the landscape for pharmaceuticals, Vantage predicted that 2019 will be a year of shakeups for the industry, with biosimilars potentially playing a substantial role.

Amgen and Entera Bio have announced that they have entered into a research collaboration and license agreement to develop orally administered formulations of biologic drugs.

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.

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.

In revised draft guidance published in October 2018, the FDA announced its intention to crack down on citizen petitions that seek to delay competition from generic or biosimilar drugs.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.

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).

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.

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

The European Commission has granted a marketing authorization to Cinfa Biotech and Mundipharma’s biosimilar pegfilgrastim, Pelmeg, for all indications of the reference product, Neulasta.

Nielsen, a global measurement and data analytics company, recently revealed that direct-to-consumer healthcare advertising has reached 75% of US cancer survivors on television.

Results of a recent survey demonstrate that Asian physicians are less confident in using biosimilars than their European peers are.

Samsung BioLogics, parent company of the biosimilar development business Samsung Bioepis, has been fined by the Republic of Korea’s financial regulatory body, The Securities and Futures Commission, after the commission ruled that Samsung had committed fraud.

AbbVie has struck agreements with multiple developers over biosimilar adalimumab, forestalling US market entry until 2023. Here's when each product could potentially reach US patients.

The Canadian Agency for Drugs and Technologies in Health, the Canadian entity responsible for health technology assessments (HTAs), has released a new report that explores international policies related to biosimilars and the factors that facilitate their use.

Republic of Korea-based Celltrion has won a court decision that declared patents on Roche’s Herceptin invalid in Japan.

While US patients with HER2-positive cancers do not have an available subcutaneous trastuzumab option, Brazil, Canada, and the European Union have an approved product that has been shown in a phase 3 trial to be noninferior to intravenous trastuzumab.

After previous US regulatory setbacks, Coherus Biosciences has gained FDA approval for its pegfilgrastim biosimilar, Udenyca (pegfilgrastim-cbqv).

US voters will head to the polls next week in the midterm elections, and in the run-up to the election, the Kaiser Family Foundation has revealed that pharmaceutical companies have donated nearly $79 million to members of Congress over the past 6 election cycles.

The FDA has approved Sandoz’s biosimilar adalimumab, Hyrimoz (adalimumab-adaz).

The Salt Lake Tribune is reporting that public employees in the state of Utah could be paid by their insurance plan to fill prescriptions for high-cost drugs in Mexico instead of in their local pharmacies.

The arrival of biosimilar adalimumab in European markets has been cause for enthusiasm among those seeking greater patient access and lower costs for the treatment of rheumatoid arthritis (RA). However, AbbVie (maker of the reference adalimumab, Humira) has revealed that its oral Janus kinase inhibitor, upadacitinib, outperformed both placebo and adalimumab in a phase 3 study.

NeuClone has announced the start of its first-in-human trial of a trastuzumab biosimilar in a phase 1 trial.

China-based drug maker Innovent Biologics has revealed that China’s National Medical Products Administration has approved its application to test a combination therapy comprising a proposed biosimilar bevacizumab product, IBI305, plus sintilimab, an anti–programmed cell death protein 1 (PD-1) monoclonal antibody.

On Friday, Mylan announced that it has launched its biosimilar adalimumab, Hulio, in the European Union. Hulio’s entrance into the marketplace brings the number of available biosimilar adalimumab therapies to 4.

New research from Avalere suggests that moving Part B drugs into Part D could result in higher out-of-pocket costs for beneficiaries with rheumatoid arthritis (RA) unless policy changes are made to reduce Part D cost sharing.

Sandoz has announced that its biosimilar adalimumab, Hyrimoz, became available today in the United Kingdom, and Amgen announced that it will begin making its Amgevita available in multiple European markets.

Pemphigus vulgaris (PV) is a rare immune-mediated skin disorder, typically occurring in middle-aged and older adults, that involves painful blistering of the skin and mucous membranes. While many patients are well controlled on systemic corticosteroid treatment, steroid-sparing therapy can be desirable for treating moderate to severe forms of the disease, and rituximab is one such agent to show promise in this indication.