It is now more than 3 years since the first biosimilar agents in oncology support, erythropoiesisstimulating agents, were approved in the eu. The brazilian health regulatory agency anvisa is an autarchy linked to the ministry of health, part of the brazilian national health system sus as the coordinator of the brazilian health regulatory system snvs, present throughout the national territory. Biosimilars in the eu european medicines agency europa eu. However, because of a complex development process, biosimilars can be considered only those noninnovator biologics with satisfactory supporting evidence ranging from structural to clinical, as outlined in the recommendations by the world health organization who. In the near future, the number of biosimilar medicines is likely to grow quite rapidly fig. Biosimilars are approved according to the same standards of pharmaceutical quality, safety and efficacy that apply to all biological medicines approved in the eu. Fdas overview of the regulatory guidance for the development and approval of biosimilar products in the us. Dec 22, 2010 the regulation of biosimilars is a constantly evolving process, and the ema has the most developed regulatory system for biosimilars. What you need to knowand donow posted on april 26th, 2016 by betsy davis in pharmacovigilance. Colombian guidelines for productos bioterapeuticos similares.
Licencias obligatorias y medicamentos como bien publico 3. The arrival of biosimilar biological medicines has created just such an opportunity. Guideline on similar biological medicinal products chmp43704 rev 1 page 37 executive summary this guideline outlines the general principles to be applied for similar biological medicinal products also known as biosimilars as referred to in directive 200183ec, as amended, where it is stated that. Comparative analytical assessment and other qualityrelated considerations. As the patents of different biologics expire, companies are allowed to develop and sell these products.
The regulation of biosimilars is a process that is still developing. Compared with conventional chemical drugs, biologics are relatively large and complex molecules. Response to biosimilars in latin america posted 071120 by jodi h, gabi online editorial office dear mr spitzer, thank you for your comment. In europe, guidance regarding the approval and use of biosimilars has evolved with the products under consideration. Press release new guide on biosimilar medicines for healthcare. On the regulatory approval pathway of biosimilar products article pdf available in pharmaceuticals 54. This is the second us biosimilar approval, suggesting others may soon be on the waygood news for companies with. A biosimilar medicine biosimilar is a medicine highly similar to another biological medicine already marketed in the eu the socalled reference medicine1, 2.
Background and key issues congressional research service summary a biological product, or biologic, is a preparation, such as a drug or a vaccine, that is made from living organisms. The use of the active ingredient abn in the trade name of a biosimilar is not acceptable. Medicamentos biosimilares ensayo clinico medicamentos con. New guide on biosimilar medicines for healthcare professionals. What is the approval process for biosimilar products. All fdaapproved biological products, including reference products and biosimilar products, undergo a rigorous evaluation so that patients can. Implementing a treatment registry for a biosimilar. Practical guidance on biosimilars, with a focus on latin.
Partnership for productive development of biosimilar products. A few weeks ago, the us fda approved inflectra infliximabdyyb, a biosimilar to infliximab. Biosimilar medicines are required to have a trade name clearly distinguishable from all other products, especially the reference medicine and other biosimilar medicines. The regulation of biosimilars is a constantly evolving process, and the ema has the most developed regulatory system for biosimilars. The aim of biosimilar development is to demonstrate biosimilarity high similarity in terms of. Switching biosimilars should be considered a change in clinical management. The first biosimilar zarxio filgrastimsndz was approved in the us in march 2015, launching what some refer to as a milestone in the maturity of medical biotechnology. Companies can market approved biosimilars once the period of market protection of the reference medicine expires after 10 years. Gabi online is a repository of generics and biosimilars information. Eu contribution to the regulation of biosimilars worldwide.
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