Development

Use of the 351(k) biosimilar approval pathway entails legal challenges, high costs, and potentially higher clinical evidence standards. Sarfaraz K. Niazi, PhD, suggests that using the 351(a) pathway for standalone drugs and copy products may be faster and better. This is part 3 of a series.

Centus Biotherapeutics reports positive findings from AVANA for its bevacizumab biosimilar candidate.

Chad Pettit, MBA, executive director of Marketing and the Global Biosimilars commercial lead for Amgen, discussed the company’s 2021 Biosimilar Trends Report and his projections for the future of the biosimilars market.

After the loss of a manufacturing plant in China and a knock-down-drag-out battle with Johnson & Johnson, is Pfizer cooling on biosimilars?

The LAVENDER study demonstrates safety and tolerability of simultaneous intravenous (IV) administration of biosimilar trastuzumab (Kanjinti) and pertuzumab in cohorts of healthy volunteers.

Payers defend their policies on biosimilars in ophthalmic settings following allegations from the American Academy of Ophthalmology (AAO).

"[Payers] are incorrectly assuming that biosimilars of bevacizumab are going to behave the same as Avastin in the eye, and they’re making that assumption with absolutely no data," contends George Williams, MD, clinical spokesperson and past president of the American Academy of Ophthalmology (AAO).

Health care systems need to consistently reevaluate whether the biosimilars they utilize are the most cost-effective, Neal Dave, PharmD, the executive director of pharmacy at Texas Oncology, explains.

The road to production of biosimilar messenger RNA (mRNA) vaccines could be very swift compared with the experience for other biologics. With fewer intellectual property restrictions, small manufacturers could step right in, according to Sarfaraz K. Niazi, PhD.

After a delay caused by a manufacturing shift, Formycon and Bioeq are back on track with their ranibizumab biologics license application (BLA), and their partner Coherus BioSciences is aligned for US commercialization.

Amgen reported a strong increase in biosimilar sales for the year but said competition is forcing down prices and affecting revenues for its originator products, too.

A supply chain shortage of Avastin (bevacizumab) is prompting policies for use of bevacizumab biosimilars instead, which the American Academy of Ophthalmology says could lead to problems.

When it comes to exports, Celltrion Healthcare leads the way among Republic of Korea pharmaceuticals producers. The company's biosimilars are the leading exports.

Sarfaraz K. Niazi, PhD, discusses the regulatory approval of future messenger RNA (mRNA) vaccines, which will likely face fewer patent issues and are easy to replicate.

Pfizer reported strong sales for its biosimilars portfolio, but these were eclipsed by the massive success of the company's mRNA vaccine for COVID-19.

Concomitant use of immunomodulators and dosage are important variables in the development of antidrug antibodies (ADAs) for patients receiving infliximab for Crohn disease, investigators report.

Biocon reports on its revenues from biosimilars and the FDA status of its insulin glargine product.

Shanghai Henlius Biotech initiates a trial for patients with macular degeneration while Dong-A ST and Meiji Seika Pharma agree on a distribution plan for a ustekinumab biosimilar candidate.

Pharmacokinetic, safety, and efficacy findings for patients with inflammatory bowel disease (IBD) were presented at the European Crohn's and Colitis Organization's annual meeting.

Samsung Bioepis launches a potential pivotal trial for its SB17 ustekinumab biosimilar candidate.

Amgen's advertising appeared to push doctors and patients away from the prefilled syringe version of its pegfilgrastim (Neulasta) product, which may have a better sales future than the Onpro.

Bio-Thera's BAT2206 ustekinumab candidate is in contention with multiple other proposed biosimilars to Janssen's Stelara.

Chad Landmon, JD, chair of Intellectual Property and FDA Practice at Axinn, Veltrop & Harkrider, provides a legal perspective on the implications of President Biden’s effort to improve the competitiveness of drug markets.

Medicare lost out on over $2 billion in savings as adalimumab biosimilars were sidelined by patent restrictions, said investigators who recommended patent reforms.

Chong Kun Dang of the Republic of Korea has entered a licensing deal for the distribution of a darbepoetin alfa biosimilar in the Gulf region.

Biosimilars are launching at significant discounts to reference products and capturing increasing market share, according to an Amgen report.

Top executives of JHL Biotech are alleged to have conspired to steal secrets for development of rituximab, bevacizumab, and trastuzumab biosimilars. Two co-conspirators have pleaded guilty in the case.

Ahead of receiving regulatory approval for a "wet" age-related macular degeneration biosimilar candidate, a broad-based commercialization deal is inked.

Insulin aspart, lispro, and glargine biosimilar candidates referencing NovoRapid, Humalog, and Lantus demonstrated bioequivalence in trial data presented at the Scientific Sessions of the American Diabetes Association.

The Center for Biosimilars® provided news and insight during June 2021 in the form of interviews with key opinion leaders and coverage of major events. Catch up on what you missed.