Hepatitis C and The Making Of Biosimilars

Related Article; What Are Biosimilars ? Should I Care ?

What does Hepatitis and Biosimilars Have In Common?

Reported on the online site Goliath , Hepatitis C, Hepatitis B and HIV/AIDS is expected to contribute approximately 5% to the global biosimilar applications market by 2014.

Hepatitis C and The Making Of Biosimilars

Goliath reported in 2009 the EMEA (European Medicines Agency) rejected the application of Biopartner's Alpheon (interferon alpha), which is a biosimilar version of "Roferon A" due to the quality and clinical differences between the reference drug and its biosimilar. The company is again conducting clinical studies to match the reference drug with the branded one.

Cyplasin Biomedicals 2010 Press Release; Generic Peginterferon in USA: Cyplasin Biomedical Prepares A Biosimilar Pegylated Interferon-alpha (C-Pegferon(TM)) for Market Approval in the U.S., E.U. and Major Market Regions

Excerpt;
Cyplasin recently signed an agreement with Minapharm Pharmaceuticals to distribute and market their version of the long-acting pegylated interferon-alpha product (to be marketed and sold under Cyplasin's brand name C-Pegferon(TM)) within the North American and South American markets as well as Mexico, Latin America, Korea, Russia, China, India and other countries. Cyplasin will be one of the first companies with a biosimilar long-acting interferon-alpha formulation for treatment of hepatitis C patients in North America. Minapharm's pegylated interferon-alpha product is currently sold in the Middle East and Northern Africa region.

The combined market for ribavirin and the long-acting interferon-alpha therapy is estimated to be over $2 Billion annually and Cyplasin now has generic versions of both drugs. Cyplasin will start the process to acquire regulatory marketing approvals to sell the generic drugs in territories outside of North America this July and expects to be on track for other regulatory approvals for the North American market by 2012..... Read More....

Goliath:
The global biosimilar Hepatitis C market accounted for $9.1 million in 2008 and it is expected to be $398.5 million in 2014 with a CAGR (Compound Annual Growth Rate) of 76.5% during 2009-2014. Global biosimilar hepatitis B market was worth $12.8 million in 2008 and it is expected to grow at a CAGR of 76.5% during 2009-2014 to reach $558.5 million in 2014. The global biosimilar HIV/AIDS market is expected to be $2.2 million in 2014 with a CAGR of 61.1% during 2009-2014
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What Are Biosimilars?

Biosimilars are copycat versions of expensive biotechnology drugs. Although technically these "biosimilars" are not called generic.

Quoted from Reuters ;"Because of the complexity of biotech drugs, which are produced through biological processes that generally involve recombinant DNA technologies, they are often called "biosimilars" rather than generic copies. Biotech drugs are usually made from living cell lines controlled by different manufacturers, it is impossible for generic companies to make identical copies as they do with simple chemical-based drugs, which do not require fresh clinical trials. Biosimilars of drugs like Amgen's white blood cell-booster Neupogen are already on the market in Europe."

Today Reuters reported on the JP Morgan healthcare conference in San Francisco, where the big news was biosimilars. More drug manufactures are pursuing Biosimilars, two big players are Amgen, and Merck.
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Check it out.........
Merck BioVentures Taps Parexel to Help Develop a Range of Biosimilars
Merck teams with Parexel for biosimilars
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Written in the article ; "Kevin Sharer, chief executive officer at Amgen Inc, said the world's largest maker of branded biotechnology drugs would consider entering the "biosimilars" space, particularly in emerging markets like Asia and South America."

Read More..................


FDA to regulate Biosimilars ;

The FDA currently has not put in place regulations for " biosimilars", following hearings in November 2010, the FDA will continue to pave a regulatory pathway for biosimilars in the United States.

Upcoming Biosimilars 2011

A two day conference to "air the issues" and "raise the questions" associated with the legislation for, and applications and use of, biotech medicines currently under consideration in the United States Congress to provide the authority to the FDA to regulate Biosimilars (also called follow-on biologics or generic biologicals).

March 14-15, 2011

George Washington University -
Jack Morton Auditorium -
Washington, DC

EU adopts new biosimilar guideline

November 19, 2010 — 10:28am ET
By Liz Jones Hollis
FierceBiotech

European regulators have adopted a guideline on biosimilar antibody drugs; industry can expect its publication in a couple of weeks. However, many experts already anticipate a cautious approach, requiring separate clinical trials for different diseases addressed by the same antibody, as Reuters notes.

In a release, the EMA briefly touched on the guidelines, titled 'Similar Biological Medicinal Products Containing Monoclonal Antibodies,' which will be released for a five-month public consultation period. "This guideline lays down the nonclinical and clinical requirements for monoclonal antibody-containing medicines claiming to be similar to another one already marketed," it explains.

Earlier this week, Lincoln Tsang, a partner at London law firm Arnold & Porter, told Reuters he expects the EMA to play it safe by requiring extensive testing. "My hunch is that they will be cautious in saying that if you can establish clinical efficacy and safety of a given product for a given indication you can't readily seek approval for another indication," he said. "Given it is such a big therapeutic area, I think they will not like to be seen to be too generous."
As Reuters notes, such testing could drive up the costs of producing biosimilars, thus making it hard for smaller companies to enter the arena. If costs are too high, only well-established players like Teva, Novartis and Hospira might have the ability to bring such products to market.
- read the EMA release- get more from Reuters- see this story, also from Reuters

ALSO: The South Korean government Thursday pledged to promote the biosimilar industry, aiming to take 22 percent of the global market by 2020.
Story

Read more:
EU adopts new biosimilar guideline - FierceBiotech http://www.fiercebiotech.com/story/eu-adopts-new-biosimilar-guideline/2010-11-19?utm_medium=rss&utm_source=rss#ixzz1BLVy5YTa