New Research Report Unveils Future of Biosimilars - Applied Clinical Trials


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New Research Report Unveils Future of Biosimilars

Source: Applied Clinical Trials

Research and Markets recently released its Biosimilars Market by Product & Application - Global Forecast to 2018, which analyzes the revenue market of recombinant glycosylated proteins, recombinant non-glycosylated proteins, and recombinant peptides—the three major drug classes of that market. Highlights of the report show that oncology—currently comprising 25% of the market—will the fastest-growing segment and biosimilars of insulin will be the fastest-growing products, estimated to grow at a CAGR of 35.6% from 2013 to 2018.

Unfortunately, regulatory issues will burden this market segment. The different terminology and guidelines for biosimilars across regions will be problematic. Generic versions of biologic drugs approved under the EMA regulatory pathway and section 351K of the U.S. FDA are considered as biosimilars. In the U.S., biosimilars are also known as follow-on-proteins and have been approved under section 501(b), whereas in Canada, biosimilars are called Substituent Entry Biologics (SEB).

Geographic analysis reveals that Europe is the largest contributor to the global market. Asia-Pacific (China, India, and South Korea), North America (U.S.), and Latin America (Brazil) are poised to grow at high double-digit rates.

The global market is highly consolidated with the top three players, namely, Sandoz (Germany), Hospira (U.S.), and Teva (Israel) accounting for approximately 90% of the market share. Other notable players in the market include Dr. Reddy's Laboratories (India), Biocon Ltd. (India), Mylan (U.S.), Biopartners (Switzerland), Amgen (U.S.), and IntasBiopharmaceutical Ltd. (India).

Read the full release here.


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As it creates a plan to implement the US biosimilar pathway, should FDA:
Borrow heavily from EMA's pathway program?
Borrow lightly from EMA's pathway program?
Create entirely its own pathway program?
Borrow heavily from EMA's pathway program?
Borrow lightly from EMA's pathway program?
Create entirely its own pathway program?
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