The Coming Age of Biosimilars MArket
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The Coming Age of Biosimilars - Regulatory developments and alliance strategies intensify interest in a developing market Report Description Biosimilars are attracting significant attention at present as companies from all sectors of the biopharmaceutical market are investigating the opportunities they present. Opinion is split as to the true potential of this market with some predicting it will grow to the multi-billion dollar level within five years, while others point to the limited impact of biosimilars in Europe to date to suggest that it will never be a major threat to branded biologics. To Get Complete Details Here @ http://www.bigmarketresearch.com/the-coming-age-ofbiosimilars-regulatory-developments-and-alliance-strategies-intensify-interest-in-adeveloping-market Biosimilar pipelines are rapidly shifting away from the initial focus on the older, less complex, biologics towards the higher earning monoclonal antibodies as well as developing, so called, “biobetters” - similar biologics which offer improvements over the originator. Report Description “The Coming Age of Biosimilars - Regulatory developments and alliance strategies intensify interest in a developing market” is a consultancy-style report focused on the many increasing topics of biosimilars and their impending impact on the pharmaceutical industry. This report will provide insights into the drivers & resistors, the developing pipeline, the regulatory pathways, and the competitive landscape for biosimilars. Enquire About Report@ http://www.bigmarketresearch.com/report-enquiry/132480 Please Note: This product is delivered as a zip file Report Description Scope • Introduction, overview and drivers and barriers to the biosimilars market • Opportunity avenues and biosimilars defense strategies • Competitive landscape assessment Report Description Key Reason To Purchase • Understand the current state of the biosimilars market and the drivers & resistors which will impact the area’s future growth. • Identify & exploit effective biosimilar defense or launch strategies depending upon your company’s stance on their impending arrival. • Gain insights into the regulatory pathways currently in place, or in process, in the markets you are targeting for biosimilar entry. • Quickly get up to speed on the current global competitive biosimilar marketplace broken down by company type and region. Table Of Content • Introduction to the biosimilar market • The biosimilar pipeline • The regulatory pathways • Review of the competitive landscape • Appendix Table Of Content@ http://www.bigmarketresearch.com/the-coming-age-of-biosimilarsregulatory-developments-and-alliance-strategies-intensify-interest-in-a-developing-market FOR MORE DETAILS Visit us at : http://www.bigmarketresearch.com/the-coming-age-ofbiosimilars-regulatory-developments-and-alliance-strategiesintensify-interest-in-a-developing-market Stay With Us: TELEPHONE: +1 (855) 711-1555 E-MAIL: [email protected] 5933 NE Win Sivers Drive, #205, Portland, OR 97220 United States
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Biosimilars is defined as a type of biological product that is similar to another drug, which has already been licensed (approved) by the US FDA or European Medicines Agency. Due to their high degree of similarity with the biological reference product, they have no clinically evidenced and meaningful differences from the reference product in terms of quality, safety or efficacy. These drugs are also coined as follow-on biologics and are mostly derived from biological sources such as bacterium and yeast. The constitution of the biosimilar drugs can be either small molecules such as human insulin or erythropoietin, or complex molecules such as monoclonal antibodies. Biosimilars are increasing gaining prominence given the loss of exclusivity of big branded drugs. In Europe, biosimilars can be marketed through independent applicant following expiry of patent and market exclusivity periods of the reference product. A good example for this is Pfizer acquisition of Hospira, to gain access to the latter’s attractive biosimilars portfolio. Regulatory harmonization, naming and labelling, innovative licensure norms and route to market for the biosimilar drugs are issues expected to gain attention and traction from big drug makers in the forthcoming years.
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