The Center for Biosimilars® recaps the top news for the week of August 20, 2018.
Transcript:
Hi, I’m Samantha DiGrande for The Center for Biosimilars®, your resource for clinical, regulatory, business, and policy news in the rapidly changing world of biosimilars.
Here are the top 5 biosimilars articles for the week of August 20.
Number 5: A Japanese company has launched Celltrion’s trastuzumab biosimilar in Japan, but the product will only be sold to treat HER2-positive gastric cancers.
Number 4: The FDA has granted priority review for Alexion’s proposed long-acting C5 complement inhibitor that could help stave off biosimilar competition for the Soliris market.
Number 3: A new paper in BioDrugs argues that phase 3 studies may no longer be necessary for biosimilars.
Number 2: The United Kingdom’s National Institute for Health and Care Excellence says that it does not recommend Perjeta for routine use after surgery in patients with breast cancer, even though using the drug in combination with biosimilar trastuzumab could reduce the total cost of treatment.
Number 1: Pfizer’s proposed adalimumab biosimilar demonstrated similar efficacy, safety, and immunogenicity profiles to the reference Humira at 26 weeks of treatment in patients with rheumatoid arthritis.
Finally, last week, our e-newsletter asked whether you think that the United States’ patent system needs reform to prevent abuse by drug makers.
To view results of the poll, visit us on LinkedIn.
To read all of these articles and more, visit centerforbiosimilars.com.
Julie Reed: Why 2024 Is Important for Biosimilars
April 17th 2024Julie Reed, executive director of the Biosimilars Forum, showcases how the biosimilar industry is expected to develop throughout 2024, including major policy changes and hope for continued improvement in market share for adalimumab biosimilars.
Exploring the Biosimilar Horizon: Julie Reed's Predictions for 2024
February 18th 2024On this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum, returns to discuss her predictions for the biosimilar industry for 2024 and beyond as well as the impact that the Forum's 4 new members will have on the organization's mission.
Alvotech’s Stelara Biosimilar, Selarsdi, Receives FDA Approval
April 16th 2024Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.
A New Chapter: How 2023 Will Shape the US Biosimilar Space for 2024 and Beyond
December 31st 2023On 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.
BioRationality: Removing the Misconceptions Surrounding Interchangeability
April 15th 2024Sarfaraz K. Niazi, PhD, outlines the current state of interchangeable biosimilars in the US and policy changes needed to clear up misconceptions surrounding the meaning behind interchangeability designations.
Global Biosimilar Market Projected to Reach $1.3 Trillion by 2032
April 11th 2024The global biosimilar market is projected to surge from $25.1 billion in 2022 to approximately $1.3 trillion by 2032, with a compound annual growth rate of 17.6%, driven mainly by the increasing prevalence of cancer and the cost-effectiveness of biosimilars, as outlined in a report by Towards Healthcare.