- Biosimilar Product Information🔍
- Biosimilars approved in the US and filed for FDA approval🔍
- Biosimilars approved in the US🔍
- Review and Approval🔍
- Approved and Pending Biosimilar Applications🔍
- The State of Biosimilars in 2023🔍
- Biosimilars 2022 Year in Review🔍
- Status of U.S. Biosimilar Approvals and Pending Applications🔍
Approved and Pending Biosimilar Applications
Biosimilar Product Information | FDA
This page includes a chart of the approved biosimilar and interchangeable products. The approval ... Therapeutic Biologics Applications (BLA) ...
Biosimilars approved in the US and filed for FDA approval
Biosimilar Approval Status ; Filgrastim. Tanvex Biologics. Nypozi (filgrastim-txid) ; Infliximab. Celltrion/ Pfizer. Inflectra (infliximab-dyyb) ; Infliximab ...
Biosimilars approved in the US
In the FDA approval of biosimilars, infliximab-dyyb was approved under two brand names: Inflectra (Pfizer) in 2016 and Zymfentra (Celltrion) in 2023. On 5 March ...
An application for a proposed biosimilar generally must include information showing that the proposed product is biosimilar to a reference ...
pending. Page 2. Approved and Pending Biosimilar Applications*. *Based on publicly available information as of the date of this publication ...
Numerous biosimilar applications are currently pending at the FDA, including applications for reference products that have yet to see an approved biosimilar ...
Biosimilars 2022 Year in Review - Fish & Richardson
For example, both Alvotech and Pfizer have announced that FDA accepted interchangeability applications for their respective Humira® biosimilars, ...
Status of U.S. Biosimilar Approvals and Pending Applications
As of June 2018, 24 biosimilar applications have been filed and eleven biosimilar drugs have received FDA approval.
Biosimilars 2021 Year in Review - Fish & Richardson
Table 2 below shows selected pending biosimilar BLAs for which ... use that has not previously been approved for the reference product?
A Systematic Review of U.S. Biosimilar Approvals: What Evidence ...
The approval process for the first 5 biosimilars on the market in the United States provides a baseline understanding of what type and degree of evidence is ...
FDA Proposes Dropping Switching Studies for Biosimilar ...
On June 20, FDA issued a draft guidance proposing to remove switching studies from the interchangeable biosimilar approval process.
Biosimilar medicines: marketing authorisation
The European Medicines Agency (EMA) is responsible for evaluating the majority of applications to market biosimilar medicines before they can be approved and ...
Biosimilars and biologics litigation in the United States - IAM Media
the biosimilar applicant has 20 days to notify the reference product sponsor (RPS) that the FDA has accepted the biosimilar application;; within ...
A “period of exclusivity” exists during which biosimilars may not be approved. According to the FDA, no application may be submitted until four years and ...
Biosimilars 2020 Year in Review | Fish & Richardson - JDSupra
The following tables summarize publicly available information regarding approved and select pending biosimilar Biologics License Applications ( ...
Biosimilars: Part 1: Proposed Regulatory Criteria for FDA Approval
The FDA also has the flexibility to decide which, if any, pre-clinical and clinical data are required to support a biosimilar application. · Comparative clinical ...
The Use of Biosimilars in Ophthalmic Practice - 2022
Any differences between the proposed biosimilar product and the reference product are evaluated by FDA to ensure the biosimilar meets the FDA's approval ...
The Complexities of Biosimilars and the Regulatory Approval Process
The FDA approves a biosimilar after a manufacturer establishes that the product is highly similar to a previously approved originator biologic reference ...
Pipeline spotlight: Humira biosimilar products Q2 2024 - CarelonRx
Unbranded adalimumab products are marketed under a manufacturer's approved Biologics License Applications (BLA) without its brand name on label.
Federal Circuit Denies Injunction Pending Appeal After Amgen Beat ...
As we previously reported, FDA approved Amgen's PAVBLU on August 23, 2024, after previously approving aflibercept biosimilar applications filed ...