Regulatory

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.

China has approved a product for rheumatoid arthritis and Crohn disease that Mabpharm and Sorrento Therapteutics say is an improvement on infliximab.

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.

On this week’s episode of Not So Different, we spoke with David Senior, senior vice president of Market Economics at AmerisourceBergen, about the development of the generics market and how this could be instructive in understanding how biosimilars sales may develop.

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

An advertisement for the Onpro wearable pegfilgrastim injector kit has the potential to undermine sales of biosimilars, the FDA stated in a warning letter.

Panelists at the American Conference Institute's 2021 meeting took on the complexities of biosimilar adoption in a wide-ranging discussion.

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.

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

Following the release of a whitepaper on sustainable generics and biosimilars markets, members of a trade association discussed concerning trends for the industry.

In a white paper, the International Generic and Biosimilar Medicines Association (IGBA) describes industry dynamics that it says affect market sustainability and patient access.

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.

AVT04 (ustekinumab) if approved would be targeted at an estimated $7.7 billion market for the reference product, Stelara.

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.

The Supreme Court’s ruling in the Affordable Care Act (ACA) case appears to have saved the biosimilars approval pathway, but do the plaintiffs have other avenues by which to bring another challenge?

Teva and Bioeq partner on ranibizumab, Organon joins the Biosimilars Forum, and the Alliance for Patient Access issues educational material for oncology biosimilars.

Early study results indicate that STADA Arzneimittel and Xbrane Biopharma’s ranibizumab biosimilar is as safe and effective as the reference product, suggesting regulatory approval may be on the horizon.

The BIOSIM Act would increase the add-on payment for use of a biosimilar, thereby incentivizing practitioners to use these products more often, according to proponents of the bill.

Innovent Biologics said based on success of ORIENT-32, China's National Medical Products Administration (NMPA) has approved sintilimab in combination with bevacizumab biosimilar (Byvasda) in front-line unresectable hepatocellular carcinoma.

Authors of an opinion piece suggest that a "reliance" approach to biosimilar approval could lead to global standards for acceptance that cut down on wasted review time and obsolete clinical investigation.

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has favored marketing authorization for the ranibizumab biosimilar (Byooviz, SB11) based on phase 3 study findings.

A turning point for interchangeable biosimilars has arrived, as the first may be approved this year, but many questions about these agents have yet to be answered, according to Laura Sim, senior counsel for Amgen.

Tahir Amin, Dip LP, co-executive director of I-MAK, discusses some hot-button issues regarding the US patent system, including AbbVie’s alleged abuse of it, and his hopes for improvement.

Investigators report survival data for the bevacizumab biosimilar Byvasda with sintilimab (Tyvyt) in hepatitis B virus–associated advanced hepatocellular carcinoma (HCC).

Ping Cao, vice president of Business Development for Shanghai Henlius Biotech, discussed the company's current biosimilar development plans and the process for getting regulatory approval for biosimilars in China.

Getting to the stage where clinical data on interchangeability are reportable to the FDA is a key milestone in Alvotech’s bid to get its high-concentration adalimumab biosimilar approved and on the market.

A technicality—inability to demonstrate harm—frustrated plaintiffs whose case threatened to sink not just the Affordable Care Act but also the Biosimilars Price Competition and Innovation Act (BPCIA), the pathway for biosimilars approvals.