Gastroenterology

The interchangeable designation allows pharmacists more flexibility to dispense this potentially money-saving product and gives Boehringer Ingelheim a marketing edge.

The court battle between AbbVie and Alvotech could be a defining victory in the struggle to bring biosimilar versions of adalimumab to market, but a yearlong court process must play out first.

Preventing the nocebo effect requires a demonstration of confidence in biosimilars from all health care practitioners, including pharmacists, experts said in a newly published rheumatology treatment guidance document.

Studies of the infliximab biosimilar Remsima in patients with inflammatory bowel disease were presented at United European Gastroenterology Week 2021.

The month of September 2021 was chock-full of biosimilar news. From regulatory actions to policy initiatives to clinical news, no dust was gathering on the road toward wider biosimilar adoption.

In a biosimilar trend report, Amgen discusses marketing achievements, US biosimilar policy, payer and provider acceptance of these agents, and the outlook for further growth.

Reykjavik, Iceland company Alvotech said the FDA review of its adalimumab candidate is held up by pandemic-related curbs on overseas inspections.

Refinements to the analytical testing of biosimilar candidates to verify similarity were worked into 2019 guidance from the FDA. These changes offer what the author considers a more "rational approach."

The findings support Alvotech's bid for interchangeable status for the high-concentration, citrate-free adalimumab biosimilar candidate.

The strength of a patent wall built up around an originator biologic depends on the quality of patents that make it up and the originator company's willingness to engage in costly litigation. Part 2 of a series.

In this first part of a series, intellectual property attorneys from the Biotechnology Innovation Organization (BIO) contend that originator patents are not the formidable obstacles to biosimilars they are made out to be.

Misperceptions of biosimilars contribute to low acceptance of these products. Two Cardinal Health researchers discuss barriers to understanding and the importance of biosimilar education.

Clinical efficacy studies are not always required for biosimilars, and it's possible to resist if the FDA does ask for them. Sarfaraz K. Niazi, PhD, suggests a game plan.

CVS Caremark has reordered its list of preferred therapeutics, adjusting the emphasis on biosimilars, and demonstrating that preferential status can change at any time.

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.

Worries about what HHS will propose in its anticipated biologics pricing reform policy have been exacerbated by a rumored coding change.

A group of 16 advocacy groups are urging HHS to make zero co-pays for biologics a part of its prescription drug price reform program.

Passage of HR 3 is shaping up as a centerpiece of President Biden's effort to bring pharmaceutical prices under control. If drug companies won't negotiate prices, international reference pricing would kick in.

When it comes to their willingness to use biosimilars, providers and managed care pharmacists prefer greater transparency on formulary placement and costs, according to a focus group study based on health care surveys.

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.

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.

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