News

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.

Prerakkumar Parikh, PharmD, and Sneha Sharma, PharmD, from Magellan Rx Management, tackle some of the biggest concerns ophthalmologists have regarding emerging biosimilars for ophthalmic conditions, including interchangeability as well as lack of real-world evidence and education.

In a real-world study in India, patients with ankylosing spondylitis who were treated with the adalimumab biosimilar Exemptia for 10 weeks showed improvements in disease activity that persisted through 48 weeks.

Here are the top 5 biosimilar articles for the week of July 3, 2023.

Four pharmacists offer advice for clinics on how to prepare for new self-administered biosimilar products, including adalimumab biosimilars, and overcome emerging administrative challenges.

The US gains 2 more adalimumab biosimilars on the market: Fresenius Kabi's Idacio (adalimumab-aacf) and Biocon Biologic's Hulio (adalimumab-fkjp). The launches come after 5 launched over the Fourth of July weekend.

Long-term results comparing ranibizumab biosimilar SB11 vs reference ranibizumab (Lucentis) on neovascular age-related macular degeneration (nAMD) support biosimilarity between the treatments.

Celltrion USA launched its fifth biosimilar in the United States, Yuflyma (adalimumab-aaty), a biosimilar referencing Humira that is also 1 of 8 adalimumab products expected to launch in July.

On this episode, we’re going to be recapping some of the biggest stories in the business space regarding biosimilars, including adalimumab preparation, partnerships for commercialization, and more.

After years of waiting and legal battles, the first of the 8 adalimumab biosimilars expected to launch in July 2023 have entered the market.

As the US biosimilar industry prepares for a busy summer, businesses worldwide make strides to elevate their biosimilars portfolio, from some business extending and strengthening their partnerships to new deals for adalimumab products ahead of US launches.

Here are the top 5 biosimilar articles for the week of June 26, 2023.

It was found that cancer treatment, pediatric population, and coverage restriction of reference products were revealed as some of the strongest factors associated with biosimilar coverage decisions by US commercial health plans relative to reference products.