News

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.

Real-world study in Italy finds most patients with inflammatory bowel disease (IBD) maintain clinical and biochemical response after switching from infliximab reference product to SB2.

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

Here are the top 5 biosimilar articles for the week of July 12, 2021.

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.

Presentations at the European Crohn's and Colitis Organization annual meeting supported the transition to adalimumab biosimilars and provided patient acceptance data.

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.

Here are the top 5 biosimilar articles for the week of July 5, 2021.

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.

Here are the top 5 biosimilar articles for the week of June 28, 2021.

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.

Investigators reported high overall response rates and savings of roughly $1400 per patient across cohorts.

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.

Sizeable savings per patient with non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL) were anticipated by a Medicare savings model.

Here are the top 5 biosimilar articles for the week of June 21, 2021.

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.