Rheumatology

A report from Artemetrx details 2020 changes in demand for biosimilars and other specialty drugs, according to health plan spending. Dynamics that could affect future spending are also explained.

Semglee (insulin glargine) will be the first test of the FDA's interchangeability concept for biosimilars, but Viatris aims to grow its biosimilar revenues with multiple products.

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

BioFactura looks to join the ustekinumab biosimilar race and Cardinal Health provides an interactive tool with state-by-state interchangeable rules.

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.

The Biologics Price Competition and Innovation Act (BPCIA) provides a stepwise approach for fact-finding prior to patent litigation, but companies may choose their own path, case examples show.

Without disclosing terms, Pfizer said it has settled with Johnson & Johnson (J&J) over a long-running dispute in which J&J was alleged to have blocked payers from covering Inflectra.

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.

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.

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

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.

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.

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 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.

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.

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.

Cigna said it will push biosimilar forms of infliximab onto the preferred list and reward patients who make the switch.

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.

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.

Sophia Z. Humphreys, PharmD, MHA, explains how biosimilar utilization management can enable health care institutions to put COVID-19–related financial wreckage behind them.

Amneal Pharmaceuticals develops its biosimilar pipeline with mAbxience, Xcenda estimates biosimilar effect on originator pricing, and Magellan Rx Management touts oncology biosimilars savings.

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.

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.