biosimilar

(redirected from Biosimilars)
Also found in: Dictionary.

biosimilar

(bī′ō-sĭm′ə-lər)
adj.
Highly similar in function and effect to an existing biological product, especially to a biologic that has already been clinically tested and approved for use.
n.
A biological product that is biosimilar to an existing product, especially to a biologic.

biosimilar

adjective Referring to a biosimilar therapeutics agent.
 
noun A biopharmaceutical which is produced by a different manufacturer after the expiration of the patent and marketing exclusivity of an original innovative biological product (e.g., a therapeutic monoclonal antibody).
 
In contrast to small (non-biological) agents, for which manufacturing an equivalent product is a relatively straightforward chemical process, biosimilars are not produced from the original clones and cell lines used to produce the tested and proven-effective agent; they thus may have therapeutic and metabolic profiles that differ from the clinically tested and proven products.

biosimilar

(bi?o-sim'i-lar) [ bio- + similar]
1. A generic version of a biologically active pharmaceutical agent, e.g., of a manufactured antibody or hormone.
2. Pert. to such a generic version.
Synonym: follow-on biologicbiosimilarity
References in periodicals archive ?
The Global Biosimilars Market is expected to grow from USD 6738.14 Millions in 2018 to USD 28903.56 Millions by the end of 2025 at a Compound Annual Growth Rate (CAGR) of 23.12%.
Conference chair, Michel Mikhail, International Expert in Regulatory Affairs, Global Expert Biosimilars, invites prospective delegates to join the conference and hear from prominent speakers and key opinion leaders within the biosimilars industry to share their experiences and evaluate regulatory framework.
[USPRwire, Mon Aug 19 2019] The retinal biosimilars market has witnessed a remarkable boost with the approval of several retinal biosimilars in 2017.
Unfortunately, many biosimilars are not available to patients even after they have successfully navigated the stringent regulatory process to obtain FDA approval.
The Government recognises the importance of driving biosimilar uptake to create a competitive and sustainable biosimilars market.
Gordon added: "Following several recent launches in Europe, we are excited to be launching our first two biosimilars in the US, which will provide for immediate savings for Medicare patients and commercial payers.
* Biogen and its collaboration partner Samsung Bioepis are the first companies in Europe to market biosimilars that reference the three most prescribed anti-TNF biologic treatments, with approximately 145,000 patients currently on treatment1
Biosimilars have great potential to reduce health care costs but have been slow to gain traction in the pharmaceutical market.
If indications are clear, global health economics is tilting the focus to biosimilars as the need for these cost-effective drugs by governments and patients becomes more compelling.
There are all kinds of reasons given for the poor uptake of biosimilars but some of them concern patients' confusion over different names different looking tablets or capsules.
Xbrane is also accelerating development of Xcimzane (certoizumab pegol [Cimzia] biosimilar) and Xoncane (pegaspargase [Oncaspar] biosimilar) and aims to develop two additional biosimilars on biologics with patent expiration 2026-2028.
Non-Hodgkin's lymphoma (NHL) has the largest number of indications for monoclonal antibodies, and rituximab--used mainly in the treatment of NHL--is the biopharmaceutical with the largest number of biosimilars developed or under development (3).