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Current Immune Aspects of Biologics and Nanodrugs: An Overview
Published in Raj Bawa, János Szebeni, Thomas J. Webster, Gerald F. Audette, Immune Aspects of Biopharmaceuticals and Nanomedicines, 2019
Biosimilars and generic drugs are versions of brand name drugs and may offer more affordable treatment options to patients. Biosimilars and generics are each approved through different abbreviated pathways that avoid duplicating costly clinical trials. But biosimilars are not generics, and there are crucial differences between biosimilars and generic drugs. For example, the active ingredients of generic drugs are the same as those of brand name drugs. In addition, the manufacturer of a generic drug must show that the generic is bioequivalent to the brand name drug. By contrast, biosimilar manufacturers must demonstrate that the biosimilar is highly similar to the reference product (Fig. 1.12), except for minor differences in clinically inactive components. Biosimilar manufacturers must also prove that there are no clinically meaningful differences between the biosimilar and the reference product in terms of safety and effectiveness.
Biosimilars in the EU
Published in Laszlo Endrenyi, Paul Jules Declerck, Shein-Chung Chow, Biosimilar Drug Product Development, 2017
Directive 2003/63/EC, published on June 27, 2003, amending Directive 2001/83/EC, defines (in Part II: Specific marketing authorization dossiers and requirements) the concept of “similar biological medicinal products,” commonly called “biosimilars” (EC, 2003). A biosimilar, as has been noted in earlier chapters, is a biological medicinal product that has been developed as equivalent to an other biological medicine already marketed (called “reference product”). The active ingredient of the biosimilar and the reference medicinal product is essentially the same, although there may be slight differences depending on the complexity of its structure and the method of production. Both the reference medicine and the biosimilar have a natural variability inherent to all biological medicinal products. A biosimilar medicinal product is authorized when it has been concluded, based on comparable data available, that those small differences between the two have no significant impact on safety and efficacy.
Trends in Biotechnology
Published in Firdos Alam Khan, Biotechnology Fundamentals, 2020
A biosimilar is a biologic medical product that is almost an identical copy of an original product that is manufactured by a different company. Biosimilars are officially approved versions of original patented products and can be manufactured when the original product’s patent expires. In 2009, the US Congress, through the Biologics Price Competition and Innovation Act (BPCI Act), created an abbreviated licensure pathway for biological products that are demonstrated to be biosimilar to or interchangeable with an FDA-approved biological product. This pathway was created as a way to provide more treatment options, increase access to lifesaving medications, and potentially lower health care costs through competition.
Biopharmaceutical supply Chain challenges in developing countries: an exploratory analysis
Published in Supply Chain Forum: An International Journal, 2021
Thiago Ibrahim, Claudia A. S. Araujo
Biological drugs are a complicated kind of medicines produced in a living system, like microorganisms, plant, or animal cell, differently from the conventional medicines, that are provided by chemical synthesis (Associação da Indústria Farmacêutica de Pesquisa 2012). They have grown in importance for being capable of treating chronic conditions, like various forms of cancer, and of controlling or cure diseases like AIDS or heart disease, with good results, that regular chemical medicines do not achieve (Brajcich, Friesner, and Schibik 2016; Gurǎu 2004). The market price of this kind of medication is extremely high if compared to conventional drugs. In the biopharmaceutical sector, there are also the biobetters and biosimilars that play an important role in the development of this sector. Biobetters are biologics that exhibit superiority over the branded biologic (ex: efficiency or clinical specificity) and permit different forms of administrating, as oral, dermatological, and inhaled formulations (Fuhr and Blackstone 2013). Biosimilars, in turn, is a medicine proved to be highly similar to an approved biological medicine (called ‘reference medicine’) (European Medicines Agency 2017) and can be produced after the expiration of the patent’s protection of the original biological drug.
Regulatory considerations in biosimilars: Latin America region
Published in Preparative Biochemistry & Biotechnology, 2021
Anurag S. Rathore, Ankita Bhargava
Biosimilars are drugs that have been demonstrated to offer similar safety and efficacy as the approved innovator product that is on the market. They are genetically engineered to be similar to the innovator product and are typically priced at a discount to that of the innovator biotherapeutic. The cost of developing a biosimilar has been suggested to be in the range of $100–$200 million, in contrast to $800 million to $1.3 billion for the development of a novel biotherapeutic.[1] To gain regulatory approval, the biosimilar manufacturer must perform extensive studies and in-depth analysis to demonstrate similarity in functionality between the reference product (RP) and biosimilar. As patents on block-bluster biologic drugs expire and governments strive to lower cost of biotherapeutic products, the global biosimilar market has shown an exponential growth. Many of the developing nations are establishing their own regulatory pathways for approval of biosimilars. In emerging markets, the sponsors are making significant investments into the development and production of biosimilars in order to tap growing opportunities in the region.[2]
Regulatory considerations in biosimilars: Middle East and Africa regions
Published in Preparative Biochemistry & Biotechnology, 2021
Anurag S. Rathore, Ankita Bhargava
In SA, the Medicines Control Council (MCC) is the statutory body that is responsible for the monitoring, evaluation, regulation, performance, registration, and control of medicines, medical devices, and clinical trials. Within the MCC, the Biological Medicines Committee analyses biological agents, including biosimilars. In 2012, the MCC released the final guidelines for biosimilars in SA.[8] These follow the underlying principles of biosimilars guidelines from both the European Union (EU) and the World Health Organization (WHO). As per the MCC guidelines, a biosimilar is a biological medicine that is similar, but not identical, to an already registered RP in terms of quality, safety, and efficacy.[9]