- Bone Health
- Immunology
- Hematology
- Respiratory
- Dermatology
- Diabetes
- Gastroenterology
- Neurology
- Oncology
- Ophthalmology
- Rare Disease
- Rheumatology
The Top 5 Biosimilars Articles for the Week of August 20
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.
Senators Introduce Bipartisan Legislation to Protect Skinny Labeling
January 2nd 2025To close out the year, 4 senators came together to introduce a new bipartisan bill to protect biosimilar and generic drug manufacturers from patent litigation when obtaining “skinny label” approvals for their products.
Biosimilars Policy Roundup for September 2024—Podcast Edition
October 6th 2024On this episode of Not So Different, we discuss the FDA's approval of a new biosimilar for treating retinal conditions, which took place in September 2024 alongside other major industry developments, including ongoing legal disputes and broader trends in market dynamics and regulatory challenges.
The Top 5 Most-Read Policy Articles of 2024
December 28th 2024The top biosimilar policy articles of 2024 highlight advancements that include FDA guidance to simplify biosimilar interchangeability and CMS drug price negotiations under the Inflation Reduction Act, alongside challenges posed by pharmacy benefit manager rebate practices and the need for more active stakeholder engagement.
Top 5 Most-Read Regulatory Articles of 2024
December 25th 2024In 2024, significant biosimilar approvals were granted by the American and European regulatory agencies, including the first interchangeability designations for biosimilars referencing ustekinumab, adalimumab, denosumab, and aflibercept, marking key regulatory milestones in improving patient access to cost-effective treatments.
Empowering Vulnerable Populations: The Path to Equitable Biologic Therapy Access
December 22nd 2024Elie Bahou, PharmD, senior vice president and system chief pharmacy officer at Providence, discusses strategies to improve equitable access to biologic therapies, including tiered formularies, income-based cost sharing, patient assistance programs, and fostering payer partnerships.
