- Bone Health
- Immunology
- Hematology
- Respiratory
- Dermatology
- Diabetes
- Gastroenterology
- Neurology
- Oncology
- Ophthalmology
- Rare Disease
- Rheumatology
FDA Hopes to Accelerate Biosimilar Supplement Reviews
The agency will now review and act on original 351(k) biologics license application (BLA) supplements with clinical data within a 6-month time frame. Originally, such supplements had a 10-month goal date for review. In addition, applicants can now request the FDA refrain from taking action on supplements of 351(k) BLAs before a certain date.
On February 6, the US FDA published a new draft guidance entitled “Biosimilars and Interchangeable Biosimilars: Licensure for Fewer Than All Conditions of Use for Which the Reference Product Has Been Licensed.”
The agency will now review and act on original 351(k) biologics license application (BLA) supplements with clinical data within a 6-month time frame. Originally, such supplements had a 10-month goal date for review. In addition, applicants can now request the FDA refrain from taking action on supplements of 351(k) BLA before a certain date.
“As part of its review, FDA assesses the manufacturing process and the manufacturer’s strategy to control within-product variations. These control strategies are put in place to help ensure that manufacturers produce biological products with consistent clinical performance,” the FDA states.
The draft provides recommendations to applicants who are seeking licenses for a proposed biosimilar or interchangeable application supplements, with the aim of expediting reviews for biosimilars supplements. It can also be used to update initial biosimilar approvals when it is for fewer than all the reference product’s approved conditions.
According to the guidance, biosimilars or interchangeable products cannot be licensed for an indication by the FDA if they are protected by orphan drug exclusivity or pediatric exclusivity, until that exclusivity expires. Applicants can submit a supplement to the licensed 351(k) BLA for the previously protected indication once any exclusivity or patent expires.
The FDA recommends that when possible, an applicant who is seeking licensure for a proposed interchangeable product also seek licensure for all of the reference product’s licensed conditions of use.
Proposed biosimilar labeling will be dependent on whether the applicant seeks licensure for all or fewer of the conditions of use licensed for the reference product, according to RAPS.
Electronic or written comments on the draft can be submitted until April 7, 2020, before the final version of the guidance is released.
What Stands in the Way of Biosimilar Use Across MENA Countries?
May 21st 2025Despite the clear promise of cost savings and expanded access, the path to integrating generics and biosimilars across the Middle East and North Africa (MENA) region is tangled in a web of distrust, inconsistent policies, and deep-rooted cultural preferences for branded drugs.
Escaping the Void: All Things Biosimilars With Craig & G
May 4th 2025To close out the Festival of Biologics, Craig Burton and Giuseppe Randazzo from the Association for Accessible Medicines and the Biosimilars Council tackle the current biosimilar landscape and how the industry can emerge from the "biosimilar void."
The Trump Administration’s Drug Price Actions and Why US Prices Are Already Sky-High
May 17th 2025While the Trump administration’s latest executive order touts sweeping drug price cuts through international benchmarking, the broader pharmaceutical pricing crisis in the US reveals a far more complex web of development costs, profit incentives, and absent price controls—raising the question of whether any single policy, including potential drug tariffs, can truly untangle it.
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
Targeted Reimbursement Encourages Oncology Biosimilar Use
May 7th 2025Incentivizing physicians with modest financial bonuses may seem like a small step, but in Japan’s outpatient oncology setting, it helped push trastuzumab biosimilars toward broader adoption, demonstrating how even limited reimbursement reforms can reshape prescribing behavior under the right conditions.
