Skylar Jeremias

Posters from the American Society of Clinical Oncology’s annual meeting showed the safety and efficacy of a trastuzumab biosimilar and a denosumab biosimilar in different types of cancer.

Julie M. Reed, the executive director of the Biosimilars Forum, dives into the efforts that the Forum is taking to ensure that FDA can catch up on their inspections backlog and get biosimilar approvals back on track.

Here are the top 5 biosimilar articles for the week of July 11, 2022.

Abstracts from the European Hematology Association Congress 2022 confirmed comparable safety and effectiveness profiles between 2 rituximab biosimilars and the reference product (Rituxan) in patients with large B-cell lymphoma.

A letter penned by Sarfaraz K. Niazi, PhD, advocating for the banning of animal testing requirements for biosimilar development was published in Science, suggesting the journal has softened to the idea that animal testing may not be as useful as originally thought.

On this episode of Not So Different, we spoke with Sonia T. Oskouei, PharmD, BCMAS, DPLA, vice president of biosimilars at Cardinal Health, to discuss the US launch of Byooviz, the first ophthalmology biosimilar in the United States, and how it's expected to impact ophthalmology care.

Here are the top 5 biosimilar articles for the week of July 4, 2022.

As Alvotech announced that dosing of patients with its aflibercept biosimilar candidate has begun, Viatris announces its third recall for a batch of its insulin glargine biosimilar over missing labels.

During its annual conference in Sitges, Spain, Medicines for Europe recommended policy reforms for strengthening European health systems, including the use of off-patent medications like biosimilar and generic drugs.

So far in 2022, the United States has taken some big steps in increasing biosimilar access and adoption throughout the nation, including 3 FDA approvals, an investigation into pharmacy benefit managers, and progress on congressional action.

Julie M. Reed, the executive director of the Biosimilars Forum, explains what needs to be done to ensure progress on biosimilar legislation and lower drug prices.

Here are the top 5 biosimilar articles for the week of June 27, 2022.

June brought with it several updates for biosimilars and the companies that make them, including the US launch of the first ranibizumab biosimilar, a new partnership between Organon and Shanghai Henlius Biotech, and the announcement of Sandoz’ global biosimilar initiative.

Shanghai Henlius Biotech announced the commencement of a phase 3 trial for its denosumab biosimilar (HLX14) referencing Xgeva in postmenopausal patients with osteoporosis with a high risk of fracture.

Having patients meet with a clinical pharmacist before a rheumatologist could help improve biosimilar adoption rates and mitigate the nocebo effect in patients with chronic diseases, according to a recent study.

Although a lot of discussion regarding biosimilars has focussed on patient access, we need to divert more attention to the reliability of companies making biosimilar products, said Gillian Woollett, MA, DPhil, vice president and head of regulatory strategy and policy at Samsung Bioepis.

The European Committee for Medicinal Products for Human Use (CHMP) recommended 2 biosimilars for approval: Celltrion Healthcare’s bevacizumab candidate and Formycon’s prospective ranibizumab product.

Here are the top 5 biosimilar articles for the week of June 20, 2022.

Formycon’s completed acquisition of 2 biosimilar assets and start of development for 2 others provide hope for investors as the company announced some expected losses during the first quarter of fiscal year 2022.

Jeffrey Casberg, vice president of pharmacy at IPD Analytics, discussed the different options that payers have to manage the growing number of biosimilars referencing Humira (adalimumab) that are expected to enter the market in 2023 and beyond.

Abstracts from the 2022 European Hematology Association (EHA) Congress presented positive data for 2 biosimilar candidates referencing Soliris (eculizumab).

Not long after the company announced its new global initiative to promote access and increase adoption of biosimilars, Sandoz’ biologics license application for its high-concentration adalimumab biosimilar was accepted by the European Union’s regulatory agency for review.

The Biden administration must follow through on its promises, and Congressional leaders must do more to push through bipartisan biosimilar policies to encourage better adoption and lower drug costs, according to Julie M. Reed, the executive director of the Biosimilars Forum.

Here are the top 5 biosimilar articles for the week of June 13, 2022.

Abstracts from the American Society of Clinical Oncology (ASCO) annual meeting took a look at the impact biosimilar substitution and increased biosimilar adoption had on spending within practices participating in value-based payment models and the Oncology Care Model.

Iceland-based Alvotech announced that the pureplay biosimilars company is debuting on the public market starting June 16.

The FDA granted a new indication for rheumatoid arthritis for Riabni, a rituximab biosimilar, and Organon and Shanghai Henlius Biotech entered into a licensing agreement for 2 oncology biosimilar candidates.

Gillian Woollett, MA, DPhil, vice president and head of regulatory strategy and policy at Samsung Bioepis, outlines how concerns over the safety and efficacy of biosimilars has shifted and what new concerns the industry is focusing on.

STADA Arzneimittel and Alvotech announced the launch of their high-concentration, citrate-free adalimumab biosimilar (Hukyndra) in France, Germany, Finland, and Sweden, with more European countries to come.

Here are the top 5 biosimilar articles for the week of June 6, 2022.