Friday, February 16, 2007

More on Generic Biologics

This was in the Washington Post:

Generic Biotech Drugs Could Save $71B

The Associated Press
Thursday, February 15, 2007; 12:06 AM

NEW YORK -- Patients and health insurance providers could save at least $71 billion over 10 years if there was a regulatory mechanism that allowed for the marketing of generic biotech medicines, according to a study being released Thursday.

Currently there is no legal pathway that allows generic drug makers to produce biotech medicines, so the pricey treatments, which are derived from a living source such as proteins, have never had to compete with copycat products that drive pharmaceutical costs lower.

Controlling the cost of biotech medicines has become a top priority for those providing health insurance because the cost of such treatments is dramatically increasing. Biotech treatments now account for 25 percent to 30 percent of a company's overall drug costs, according to pharmacy benefit manager Express Scripts Inc., which conducted the study.

Express Scripts said that the average biotech drug costs $71,600 a year, compared with the annual average for a traditional drug of $1,200. It said that escalating biotech drug costs, which reached $40 billion in 2005, are expected to more than double in four years to a total of $90 billion in 2009, a rate three times faster than traditional drug costs.

But on Wednesday, a bill was introduced by a group of bipartisan lawmakers in Washington, D.C., that would give the U.S. Food and Drug Administration the authority to approve copies of biotech drugs. Similar legislation was introduced last year.

Express Scripts conducted the study by taking a 25 percent discount off brand name medicines in four classes of drugs that would already have generic competition because of patent expirations if copycat biologics were allowed. Express Scripts decided on that discount because it said that the generic version of human growth hormone sells at a 25 percent discount to its brand name counterparts in Europe.

The four categories of drugs were: insulin for diabetes, erythropoietins for anemia, growth hormones and treatments for multiple sclerosis.

Dr. Steve Miller, chief medical officer at Express Scripts, said its estimates were conservative because it didn't include other drugs that would lose patent protection over the next 10 years.

Express Scripts said a generic drug typically costs 60 percent less than its brand name counterpart. However, some experts have said that generic biologics may not be that much cheaper than their branded counterparts because it is likely the FDA will require more testing on generic biologics than chemical drug copycats. Biotech drugs are also more expensive to produce.

Kathleen Jaeger, president and chief executive of the Generic Pharmaceutical Association, said her trade group supports the new legislation and that numerous companies within the organization had expressed interest in entering the biotech arena, even though the process might be more expensive and complicated than producing generic chemical drugs.

Jaeger said that even if generic biologics were only 25 percent less than their brand name counterparts, it would be a huge savings for consumers.

"If it (the legislation) gets passed it will be a great win for consumers," she said.

Jim Greenwood, president and CEO of the Biotechnology Industry Organization, cautioned against forecasting any savings from generic biotech drugs without knowing how much testing regulators would require. BIO maintains the drugs won't be true generics because a product made from a living source can never be exactly copied.

"We would be happy to support follow-on biologics legislation as long as that legislation is consistent with some very critical principles: first and foremost of course is safety," Greenwood said.

FDA spokesman Kathleen Quinn said the agency hadn't seen the newly introduced legislation but that it plans to provide technical assistance on the bill. She added that as science has evolved, the agency may be able to eventually approve generic biologic drugs

Democrats in Congress Press for Generic Biologics

Legislation Would Allow Generic Biotech Drugs in U.S. (Update1)

By Justin Blum

Feb. 14 (Bloomberg) -- Lawmakers in the U.S. House and Senate introduced legislation that would for the first time routinely allow copies of medicines made using biotechnology.

The measures offered today would permit generic drugmakers, such as Barr Pharmaceuticals Inc. and Teva Pharmaceutical Industries Ltd., to produce medications that are now off limits to competition.

``Without action, the manufacturers of these biotech drugs can continue to charge monopoly prices indefinitely,'' Senator Hillary Clinton, a Democrat from New York, said at a news conference in Washington. ``Biotech drugs hold great promise, but we break that promise when the costs push treatments out of reach.''

Generic biotech drugs may reduce prices by almost a third and cut into the profits of brand-name biotech companies including Amgen Inc. and Genentech Inc., analysts say. Opponents of the legislation say attempts to copy complex gene-based medications could pose health risks.

Sponsors of the legislation in the House include Henry Waxman, a Democrat from California, and Jo Ann Emerson, a Republican from Missouri. Backers of a matching Senate version include Clinton and Charles Schumer, Democrats from New York.

Lawmakers introduced similar measures last year that didn't advance in the Republican-controlled Congress. Supporters say prospects have improved with Democrats in control.

Opposition is being led by the Biotechnology Industry Organization, a Washington-based group that represents makers of brand-name biotech drugs.

Passage of the legislation ``may mean that these drugs come onto the market without the testing necessary to make sure they are safe and effective,'' said Paul Winters, a spokesman for the Biotechnology Industry Organization.

FDA's Authority

U.S. law allows the Food and Drug Administration to approve generic versions of conventional drugs, made mostly through chemical synthesis, after patents expire. There is no similar process for most biotech medicines, genetically engineered versions of human proteins such as insulin or growth hormone.

Biotech drugs generated revenue of about $32.8 billion, 13 percent of the $251.8 billion in prescription sales to U.S. pharmacies in 2005, according to IMS Health Inc., a research company in Fairfield, Connecticut.

Many biotech medicines carry high price tags, and generic versions could lower prices by 20 percent to 30 percent, Elise Wang, an analyst with Citigroup Inc. in New York, said in an interview. One of the most expensive biotech medicines is Genzyme Corp.'s Cerezyme, a treatment for a rare enzyme disorder that can cost $200,000 a year.

Expiring Patents

Barr of Woodcliff Lake, New Jersey, says in lobbying literature that patents have already expired for some top- selling biotech medications, making them vulnerable to competition if lawmakers act. Among the products listed is an anemia treatment sold in the U.S. by Amgen as Epogen and by Johnson & Johnson as Procrit. U.S. sales of the drugs, sold by both companies under a marketing agreement, totaled $4.71 billion in 2005.

A report from Citigroup says that one of Amgen's patents lapsed in 2004 and others expire in 2012 through 2015.

Conventional drugs are small molecules that generic makers can reproduce in versions that are almost identical to the original product and change little from batch to batch.

Biotech medications use bacterial cells to produce human proteins, and the final composition can vary, depending on the techniques used.

The legislation would permit the FDA to decide whether generic makers can skip or abbreviate human clinical trials, and supporters say that would give the agency full authority to guarantee the copies are safe. Such studies aren't required for copies of conventional drugs.

Proponents of the legislation use the term ``generics'' for the biotech drugs they want to reproduce. Some brand-name makers say the drugs should be called ``follow-on biologics'' because the new versions aren't identical. European regulators call them ``biosimilars.''

Thursday, February 01, 2007

MdBio & VaBIO Launch Mid-Atlantic Bio Encyclopedia

As part of the ongoing efforts to meet the industry's long-term workforce needs, as well as to help the Mid-Atlantic community understand what the bioscience industry brings to our region and the world, the Virginia Biotechnology Association (VaBIO) is pleased to announce a new partnership with MdBIO and the National Institute of Science Media (NISM). NISM is a non-profit organization that is publishing a series of illustrated biotech encyclopedias, titled Working to Improve Lives. This is a nationally distributed series of books, published in a permanent, high quality, hardcover format. NISM recently published the first book in the series, the San Diego Life Science story, and is currently developing books covering the Mid-Atlantic region, the Bay Area, Massachusetts and Pennsylvania.

We encourage everyone to consider this opportunity to document their unique contribution to the bioscience industry. VaBIO & MdBio have worked to ensure that various levels of participation are available to meet each company's time and budget constraints. Please review each option and help us to create an amazing book showing the world the uniqueness of the Mid-Atlantic bioscience community.

Please direct any inquiries you have regarding this project to:
Joel Ball, Director, NISM
8639-B 16th St. , Silver Spring, MD 20910
1.866.NISM-123 Ext. 701/ Fax 1.866.647.6123