News

A Chinese study proved that combination therapy with sintilimab and a bevacizumab biosimilar was cost-effective enough in patients with hepatocellular carcinoma (HCC) to warrant use of the biosimilar over the reference product (Avastin) without compromising safety or efficacy.

Sarfaraz K. Niazi, PhD, gives an overview of the global biosimilar landscape, noting why some countries have biosimilars, including follow-on biologics and unbranded biologics, for certain products and why others do not.

On this episode, we’re giving a rundown of some of the biggest stories in the immunology space regarding biosimilars, like the launch of 7 adalimumab biosimilars, the release of multiple market trend reports, and clinical trial results on traditionally bypassed disease states.

Despite global sales for Amjevita (adalimumab-atto) growing by 29% year-over-year and the agent being the first adalimumab biosimilar on the US market, sales in the United States dropped 63% from the first quarter to the second quarter of 2023.

Here are the top 5 biosimilar articles for the week of July 31, 2023.

Samsung Bioepis and Organon released results from an interchangeability study of its adalimumab biosimilar; Express Scripts announced that it will add Cyltezo as well as 2 other adalimumab biosimilars to its formulary list; Anser Therapeutics will offer therapeutic drug monitoring (TDM) for Idacio.

A link is suggested between antidrug antibodies and nonresponse to biologic disease-modifying antirheumatic drugs (bMARDs) in patients with rheumatoid arthritis (RA).

Between the launch of 7 adalimumab biosimilars, the release of several market trend reports, and clinical trial results on often ignored disease states, July was a very big month for immunology biosimilars.

Abstracts presented at the annual meeting of the American Society of Clinical Oncology (ASCO 2023) emphasized the safety and efficacy of a trastuzumab biosimilar in treating HER2-positive breast cancer and growing utilization of trastuzumab biosimilars over time.

Why are companies pricing their adalimumab biosimilars with 2 prices? Can the United States expect more of this pricing strategy for future biosimilar launches? Julie Reed, executive director of the Biosimilars Forum, has the answers.

Authors of a study examined changes in pricing, market share, and utilization of the tumor necrosis factor (TNF)–α inhibitors infliximab, etanercept, and adalimumab as the first and second biosimilars for each molecule were introduced in Europe.

Here are the top 5 biosimilar articles for the week of July 24, 2023.

Reference bevacizumab and proposed biosimilar (BAT1706) demonstrate high similarity to each other.

Formycon and Celltrion announced the FDA submissions for their aflibercept biosimilars; the European Medicines Agency accepted a marketing authorization application for an ustekinumab biosimilar; and Roche filed suit against Biogen over a tocilizumab biosimilar.

The Association for Accessible Medicines (AAM) published a white paper on the impact that ongoing drug shortages have had on the generic and biosimilar industries as well as possible solutions stakeholders can put into action.

Sarfaraz K. Niazi, PhD, details his efforts to encourage congressional leaders to draft legislation that would remove interchangeability requirements and animal toxicology studies for biosimilars.

Julie Reed, MS, executive director of the Biosimilars Forum, takes a look at the 3 policy initiatives that could have the greatest ramifications for the US biosimilars industry.

Here are the top 5 biosimilar articles for the week of July 17, 2023.

A new analysis finds branded insulin glargine (Lantus) still has a majority of total market volume and new drug starts despite competition from Semglee, an interchangeable biosimilar.

The second edition of Samsung Bioepis’ Biosimilar Market Report shows strong correlation between biosimilar usage and decreased drug prices, proving that biosimilars are delivering on the promise of savings and price erosion.

Biosimilars may be able to increase treatment access for traditionally excluded communities, especially racial and ethnic minority populations.

The list price of Humira (reference adalimumab) has risen so dramatically over time that the list prices for new adalimumab biosimilars are now significantly higher than the original price of the originator, according to a report contextualizing net prices of adalimumab and the role of rebates.

Laura Wingate, from the Crohn's & Colitis Foundation, explains some of the challenges regarding educating patients and providers on biosimilars for inflammatory bowel disease (IBD) as well as whether the gastroenterology space is ready for the influx of adalimumab biosimilars.

A review article sheds light on the growing adalimumab market in the US, including how these products are being priced, strategies companies are using to make their product stand out, and recommendations for policymakers to ensure the accessibility and affordability of these products.

Senator Mike Lee (R, Utah) reintroduced the Biosimilar Red Tape Elimination Act to Congress. The bill aims to get rid of switching study requirements for companies looking to obtain an interchangeability designation for a biosimilar.

Here are the top 5 biosimilar articles for the week of July 10, 2023.

Kashiv Biosciences announced positive phase 1 results for its omalizumab biosimilar; Dongkook Pharmaceutical shared the launch of an insulin glargine biosimilar (Glargia); and Quebec, a province in Canada, said it’s adding a ranibizumab biosimilar (Byooviz) to its reimbursement list.

Multiple real-world infliximab biosimilar switches appear to be safe and effective in a real-world inflammatory bowel disease cohort study.

Noninferiority and comparable safety and immunogenicity between biosimilar romiplostim (ENZ110) and innovator romiplostim (Nplate) were identified in patients with chronic immune thrombocytopenia.

Sarfaraz K. Niazi, PhD, flagged an upcoming FDA meeting where stakeholders can make public comment on whether clinical efficacy testing for biosimilars is necessary for regulatory approval.