Global Biosimilars Market Comprehensively Examined in New Research Report by Industry Experts30 Nov 2012 • by Natalie Aster
Biosimilars or follow-on biologics can be defined as officially-approved later variants of innovator biopharmaceutical products that are manufactured by a different company after patent and exclusivity have expired on the innovator product. In Canada, biosimilars are called subsequent entry biologics (SEBs), and the approval process necessitates reference to the innovator product.
As a rule, biologics display a high degree of molecular complexity, when compared to common small molecule drugs, and are extremely susceptible to alterations in production techniques. Biosimilar manufacturers have no access to the innovator molecular clone and original cell bank, in addition to the precise fermentation and purification procedure and the active drug substance. Further, they are not aware of the commercialized innovator product, and variations in impurities and/or breakdown products could result in serious adverse health effects. As a consequence, several concerns are being raised about the performance efficacy of biologic copies, compared to the original branded product.
Therefore, the United States has authorized a limited number of subsequent versions of biologics, based on simplified processes permitted for small molecule generics, which include Menotropins (January 1997) and Enoxaparin (July 2010), in addition to another eight biologics through the 505(b) route.
According to the report “Global Biosimilars Market - Products, Applications and Regulations” by Industry Experts, European regulatory authorities have taken the initiative by adopting a special approval procedure for authorizing succeeding variants of hitherto approved biologics. This process follows the meticulous establishment of “comparability” of the “similar” product to a currently approved product. The United States Food and Drug Administration (USFDA) is of the view of implementing new legislation for enabling biosimilars’ approval for original biologics that have been approved through the PHS Act, and the Pathway for Biosimilars Act has been introduced in the House on March 17, 2009. On March 23, 2010, President Barack Obama signed the Patient Protection and Affordable Care Act, providing the FDA with authority to sanction biosimilars that include interchangeable that are substitutable with their reference product, though they are yet to be approved. Comparability has been previously used by the FDA to approve drugs, such as Omnitrope in May 2006, though the same was like Enoxaparin to a reference product, Genotropin, which was previously approved as a biologic drug under the FD&C Act.
Global Biosimilars Market - Products, Applications and Regulations
Published: November, 2012
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More information can be found in the report “Global Biosimilars Market - Products, Applications and Regulations” by Industry Experts.
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