Regulatory

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.

The “winner-takes-all” tender process for biosimilar procurement in the European Union runs the risk of driving competitors out of the market, authors of a new survey contend.

Postmarketing retrospective studies of the rituximab biosimilar (CT-P10, Truxima) demonstrated comparable safety and efficacy for treatment of diffuse large B-cell lymphoma (DLBCL).

In this column, officials from the Biosimilars Forum and Xcenda discuss how biosimilar competition has lowered prices of originator biologics and improved patient access.

In part 2 of this panel discussion, 3 experts on India’s biologics industry discuss whether biosimilars can be produced affordably in the country and ways of improving the industry’s image.

The European Union makes it far more difficult to obtain patents on biologics, reducing the likelihood of patent “thickets” that stifle competition, the Matrix Global Advisors report states.

In part 1 of this panel discussion, 3 experts on India’s biologics industry explain what’s missing from current biosimilar regulation and what the country needs to do for its products to compete internationally.

Bio-Thera has set up a psoriatic arthritis clinical trial for BAT2506, which references Simponi.

Sarfaraz K. Niazi, PhD, a member of The Center for Biosimilars® Advisory Board, reports on his citizen petition to the FDA to rationalize testing of biosimilars.

Biosimilar manufacturers may encounter roadblocks in the months and years ahead, and generics manufacturers will find they've hit a ceiling, according to Adam Fein, PhD, CEO of the Drug Channels Institute.

More transparency in how health care money is spent could improve utilization and efficiency, panelists said at the Medicines for Europe event.

Prestige BioPharma aims to expand its drug pipeline with a $152 million research and development facility.

Biosimilar education can increase physician motivation to prescribe these alternatives to costly originator products, panelists said in a Sandoz/Reuters discussion.

The House Committee on Oversight and Reform contends AbbVie's "biosimilar defense strategy" has succeeded beyond the company's wildest imagination.