News

The European Medicines Agency (EMA) has granted marketing authorization to the first ustekinumab biosimilar, STADA Arzneimittel and Alvotech’s Uzpruvo.

IQVIA’s report on the impact biosimilar competition has had on Europe’s health care space identified ongoing challenges with biosimilar access and generating savings, calling for more policies focusing on fostering a sustainable market for years to come.

A recent study found that the COVID-19 pandemic had little impact on the knowledge and attitudes of German and Swiss pharmacists regarding biologics and biosimilars between 2020 and 2022.

Sarafraz K. Niazi, PhD, previews the new year and his hopes for the end of clinical efficacy testing for biosimilar approvals using examples from history of other scientific concepts that took time to gain traction.

Prerakkumar Parikh, PharmD, director of specialty clinical solutions at Magellan Rx Management, reacts to recent FDA approvals for the first natalizumab and tocilizumab biosimilars.

Starting April 1, 2024, Hyrimoz and an unbranded version of Humira manufactured by Sandoz will be covered across all CVS formularies.

Here are the top 5 biosimilar articles for the week of January 1, 2024.

Posters from San Antonio Breast Cancer Symposium 2023 found that combination therapies featuring trastuzumab biosimilars and other common cancer medicines were safe and effective in patients with breast cancer.

Adults with inflammatory diseases maintained disease control when transitioning from originator adalimumab (Humira) to biosimilar SB5 in a pan-European study.

The regulatory structure of biosimilar development can be safely streamlined and made more efficient and less costly, wrote authors from Sandoz, Fresenius Kabi, Boehringer Ingelheim, and Samsung Bioepis in an opinion article published in BioDrugs.

The top 5 most-read rheumatology stories of 2023 included the changing market dynamics in the adalimumab space, including new launches and interchangeability labels, as well as the addition of Stelara and Enbrel to the list of originators up for Medicare price negotiation.

On this episode of Not So Different, Cencora's Brian Biehn and Corey Ford take a look back at major policy and regulatory advancements in 2023 and how these changes will alter the space going forward.

The top 5 most-read regulatory stories of 2023 covered the FDA approvals for the first ustekinumab biosimilar and the first subcutaneous infliximab product, as well as other regulatory updates.

Here are the top 5 biosimilar articles for 2023.

The top 5 most-read conference stories of 2023 recapped some of big biosimilar takeaways from this year’s conferences, including insight into how geopolitics will impact the industry, efforts from government agencies, and strategies to increase biosimilar uptake.

The top 5 most-read oncology stories of 2023 include the US market launch of Fylnetra, the sixth pegfilgrastim biosimilar on the market, the FDA approval for an autoinjector pegfilgrastim biosimilar, and more.

The top 5 most-listened podcast episodes of 2023 covered a range of topics including the US market introduction of adalimumab biosimilars, current market trends, the role of providers in boosting adoption rates, and more.

The top 5 most-read gastroenterology stories of 2023 examined clinical data for adalimumab biosimilars, some Canadian regulatory news, and inflation rate predictions from Vizient.

Brian Biehn and Corey Ford from Cencora suggest improvements to current regulatory frameworks to better promote biosimilars for US patients and ensure market sustainability.

The top 5 most-read ophthalmology stories of 2023 concerned clinical results, approvals, and launches for ranibizumab and aflibercept biosimilars.

Here are the top 5 biosimilar articles for the week of December 18th, 2023.

At AMCP Nexus, Kimberly Maxfield, PhD, pharmacologist at the FDA, delved into how the third reauthorization of the Biosimilar User Fee Act (BsUFA III) will shape the American biosimilar market and improve development efficiency over the next few years.

The FDA approved Bio-Thera Solutions’ Avzivi (bevacizumab-tnjn), the fifth biosimilar referencing Avastin (bevacizumab) to be approved in the United States.

Sarfaraz K. Niazi, PhD, offers his perspective on FDA biosimilar education efforts and the role these efforts and stakeholder perspectives play in uplifting—or undermining—biosimilar adoption.

On this episode of Not So Different, Andres Yarur, MD, a researcher and associate professor of medicine at Cedars-Sinai Medical Center, discusses the significance of the FDA approval for Zymfentra, the world's first subcutaneous infliximab product, for patients with inflammatory bowel disease (IBD).

The biosimilar Enoxa (enoxaparin), marketed in Tunisia, demonstrated equivalence in preventing subclinical postoperative thrombotic events in patients with digestive cancers to Sanofi’s Lovenox, in a randomized controlled trial.

Here are the top 5 biosimilar articles for the week of December 11, 2023.

Two Taiwanese posters presented at the San Antonio Breast Cancer Symposium (SABCS) 2023 annual meeting evaluated the real-world implications of using trastuzumab biosimilars, particularly Ogivri (trastuzumab-dkst) in patients with HER2-postive breast cancer.

Biosim.care is a new interactive education tool that can help patients, caregivers, and providers navigate decision-making and treatment conversations for multiple disease states.

The FDA agreed to review an application for Hadlima (adalimumab biosimilar) to be granted interchangeability; The European Union’s Committee for Medicinal Products for Human Use (CHMP) gave a positive opinion for an ustekinumab biosimilar; the Biosimilars Forum expressed support for a Senate Finance Committee’s draft legislation promoting biosimilars.