June 17th 2025
Celltrion's FDA approval of Steqeyma enhances pediatric psoriasis treatment, offering flexible dosing options for children with chronic inflammatory conditions.
A Look at the Regulatory Process for Approval of Biosimilar Insulins in Europe
July 29th 2017The emergence of biosimilar insulins may help broaden access to modern insulins, increase individualized treatment options, and reduce the cost of insulin therapy. Yet many healthcare providers may not understand the concept of biosimilarity and how biosimilar medications are similar, not identical, to their reference products.
Merck Wins Tentative FDA Approval of Follow-on Insulin Glargine
July 21st 2017The FDA has granted Merck’s insulin glargine (Lusduna Nexvue) tentative approval. Merck says that its follow-on basal insulin has met all required regulatory standards of clinical and nonclinical safety, efficacy, and quality for follow-on biologics.
Critical Reflection and Global Regulatory Alignment of Complex Drugs Needed
July 20th 2017The cost of developing copy versions of complex drugs—biosimilars and follow-ons for biologics and copies of nonbiological complex drugs such as nanomedicines, including drug-carrying liposomes—can be decreased, according to a new white paper.
Judicial Review of NICE Policy That Could Restrict Drug Access
July 15th 2017The Association of the British Pharmaceutical Industry (ABPI) announced his week that it has applied for judicial review of a new budget impact test implemented by the National Institute for Health and Care Excellence (NICE).
Differences in US, EU Approvals for Enoxaparin Follow-Ons Highlight Regulatory Challenges
July 14th 2017Laboratorios Farmaceuticos ROVI (ROVI), a Spanish specialty healthcare company, reportedly expects to launch a biosimilar enoxaparin, a low-molecular-weight heparin (LMWH) product, in the European marketplace by the end of 2017. ROVI requested marketing authorization for its biosimilar product in Europe in 2014.
FDA's ODAC Recommends Approval of Biosimilar Bevacizumab and Trastuzumab
July 14th 2017The FDA’s Oncologic Drugs Advisory Committee (ODAC) convened today to consider Biologics License Applications (BLAs) for 2 biosimilar products: ABP 215, Amgen’s bevacizumab biosimilar candidate (referenced on Avastin), and MYL-1401O, Mylan and Biocon’s biosimilar trastuzumab candidate (referenced on Herceptin).
House Passes FDA Reauthorization Act
July 13th 2017On Wednesday, the US House of Representatives passed the FDA Reauthorization Act of 2017 (FDARA), which, among other provisions, reauthorizes user fees for biosimilar product applications. The bill, sponsored by Representative Greg Walden (R-Oregon), was passed by a voice vote.
European Stakeholders on Biosimilar Labeling: More Education, Clarity, and Transparency Needed
July 13th 2017To gain an understanding of how stakeholders use or consult medicinal product information and to investigate their preferences for the content of biosimilar labels, a multi-stakeholder workshop was held in Brussels, Belgium.
Patent Trial and Appeal Board Strikes Down Key Humira Patent, Again
July 12th 2017Last week, the US Patent and Trademark Office’s Patent Trial and Appeal Board (PTAB) ruled to invalidate AbbVie’s patent on a method of treating rheumatoid arthritis using adalimumab (Humira). The PTAB deemed the claims in question unpattentable because of their obviousness.
FDA Seeks Comments on Its Program for Enhanced Review Transparency and Communication
July 10th 2017On June 29, the Federal Register published the FDA’s request for comments concerning its statement of work for an assessment of the Program for Enhanced Review Transparency and Communication for original 351(k) Biologics License Applications.
Biocad Expects Marketing Authorization in India for Its Rituximab Biosimilar
July 10th 2017Biocad has announced that, on June 20, India’s Central Drugs Standard Control Organization (CDSCO) recommended its rituximab biosimilar (Acellbia) for approval. The company expects to receive a permanent marketing authorization for the product in August, and anticipates that it will begin shipping the treatment to India by September.
French Inspectors Find Major Deficiencies at Biocon's Manufacturing Facility
July 10th 2017France’s health regulatory body, the French National Agency for Medicines and Health Products Safety (ANSM), found that Biocon has failed to comply with good manufacturing practice requirements for 3 of its biosimilar products manufactured at the company’s Bommasandra facility in Bangalore, India.
UK Seeks to Collaborate With EMA as Patients Fear Rising Costs, Shrinking Access
July 7th 2017The UK government sought to reassure citizens this week that “Brexit,” or the United Kingdom’s withdrawal from the European Union (EU)—and therefore its withdrawal from the European Medicines Agency (EMA)—would not negatively impact patient access to pharmaceuticals.
The STRONGER Patents Act Could Create Roadblocks for Biosimilars
July 6th 2017A bipartisan bill, introduced by US Senators Chris Coons (D-Delaware), Tom Cotton (R-Arkansas) Dick Durbin (D-Illinois), and Mazie Hirono (D-Hawaii), seeks to make a number of reforms that would make it easier for innovators—including the manufacturers of reference biologics—to defend against challenges to their patents.
Coherus Terminates 30% of Its Workforce After FDA's Complete Response Letter
July 3rd 2017Just 2 weeks after Coherus BioSciences announced that it had received a complete response letter (CRL) from the FDA in response to its biologics license application for a pegfilgrastim biosimilar candidate, the company has laid off 51 employees, or approximately 30% of its workforce, in a bid to cut its operating costs by $10 million.
Physicians Express Concerns About Biosimilar Interchangeability to FDA
June 30th 2017The 52 comments the FDA received during the public commentary period on the agency’s January 2017 draft guidance, Considerations in Demonstrating Interchangeability With a Reference Product, included statements from physicians concerned about the proposed policy.