Navigation Links
Huge Potential in Biosimilars if Generic Providers Overcome Regulatory Hurdles
Date:4/22/2008

NEW YORK, April 22 /PRNewswire/ -- Some of the biggest-selling biologics developed during the boom years in biotech of the 1980's, including human growth hormone (hGH) and insulin, have lost patent protection in the U.S. in 2007 or will shortly, and they represent a market of $40 billion. This opens up a huge potential market for biosimilars, if regulatory hurdles can be overcome, according to a new report by Kalorama Information, Biogenerics: the World Market for Biosimilars.

Worldwide interest in biosimilars is gaining momentum and is expected to reach $5.8 billion by 2012. But first such stumbling blocks as safety, access to innovators' key intermediates, process controls, availability and access to bulk materials, specifically designed and adapted analytical procedures and validation studies must be addressed. Also, biosimilars cannot currently be marketed in the U.S. because there is no pathway for them to reach the market.

"Right now, there is limited competition in biosimilars due to the complicated regulatory process and the high costs," notes Mary Anne Crandall, senior analyst for Kalorama. "But this won't last forever, and in fact in the near-term we should see some technological changes and political shifts that will fuel the market."

Biosimilars have been selling outside of the U.S. for years, creating a small existing market. As the industry is allowed in the U.S., which Kalorama predicts will happen in a serious way by 2009, it will grow exponentially. Growth will likely occur around a few big biopharmaceuticals at first.

Kalorama Information's report Biogenerics: the World Market for Biosimilars identifies the biopharmaceuticals that have lost patent protection and are likely to be the first products attempted by generic companies. Current and future trends, market size and projections are also provided. The report can be purchased directly from Kalorama Information by visiting http://www.kaloramainformation.com/Biogenerics-1399521/.

About Kalorama Information

Kalorama Information supplies the latest in independent market research in the life sciences, as well as a full range of custom research services. Kalorama routinely assists media with healthcare topics, and can provide experts to speak about markets in the life sciences industry. For more information, contact Andrea Hiller at 212-807-2673 or press@kaloramainformation.com, or visit http://www.kaloramaInformation.com.


'/>"/>
SOURCE Kalorama Information
Copyright©2008 PR Newswire.
All rights reserved

Related biology technology :

1. Systems Medicine (SM), a Subsidiary of Cell Therapeutics, Inc. (CTI), Announces Execution of CRADA with NCI/NIH to Develop Potential Cancer Treatments Targeting the Insulin Growth Factor (IGF) Pathway
2. Study Published in Clinical Cancer Research Confirms Potential Of Peregrines Bavituximab Combined With Radiation In Lung Cancer
3. Gladstone scientists uncover potential mechanism of memory loss in Alzheimers disease
4. New Data Presented on Immunocytokine Fusion Protein Further Supports Broad Anti-Cancer Potential Of Peregrines Anti-PS Technology Platform
5. Pharmaceutical Product Launch: Commercially Focused R&D Increases Drugs Market Potential
6. Agendia Acquires Rights to the Discovery of a Major Drug Resistance Mechanism in Breast Cancer Potentially Leading to a Herceptin(R) Sensitivity Test
7. AEterna Zentaris to Further Develop Three Follow-up Multi-targeted Cytotoxic Candidates to AEZS-112 as Potential Novel Cancer Treatment
8. Lexicon Files Investigational New Drug Application for LX1032 as a Potential Treatment for Carcinoid Syndrome
9. Discovery of creator gene for cerebral cortex points to potential stem cell treatments
10. Research Using Thermo Fisher Scientific RNA-Interference Technology Unveils Potential New Targets for HIV Drugs
11. Study by Leading Economist Identifies Potential for $378 Billion of Savings From Follow On Biologics
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/11/2017)... ... October 11, 2017 , ... Personal eye wash is a basic first aid supply for any ... So which eye do you rinse first if a dangerous substance enters both eyes? It’s ... Wash with its unique dual eye piece. , “Whether its dirt and debris, or ...
(Date:10/11/2017)... , ... October 11, 2017 , ... Disappearing forests and ... lives of over 5.5 million people each year. Especially those living in larger cities ... Treepex - based in one of the most pollution-affected countries globally - decided to ...
(Date:10/10/2017)... ... October 10, 2017 , ... For ... has won a US2020 STEM Mentoring Award. Representatives of the FirstHand program travelled ... Volunteer Experience from US2020. , US2020’s mission is to change the trajectory of ...
(Date:10/10/2017)... PA (PRWEB) , ... October 10, 2017 , ... ... year’s recipients of 13 prestigious awards honoring scientists who have ... presented in a scheduled symposium during Pittcon 2018, the world’s leading conference and ...
Breaking Biology Technology:
(Date:4/17/2017)... Florida , April 17, 2017 NXT-ID, ... technology company, announces the filing of its 2016 Annual Report on ... and Exchange Commission. ... on Form 10-K is available in the Investor Relations section of ... as on the SEC,s website at http://www.sec.gov . ...
(Date:4/11/2017)... BROOKLYN, N.Y. , April 11, 2017 /PRNewswire-USNewswire/ ... identical fingerprints, but researchers at the New York ... University College of Engineering have found that partial ... fingerprint-based security systems used in mobile phones and ... previously thought. The vulnerability lies in ...
(Date:4/5/2017)... KEY FINDINGS The global market ... CAGR of 25.76% during the forecast period of 2017-2025. ... for the growth of the stem cell market. ... MARKET INSIGHTS The global stem cell market is segmented ... The stem cell market of the product is segmented ...
Breaking Biology News(10 mins):