54.3 F
San Diego
Thursday, Mar 28, 2024
-Advertisement-

Biotechs in Favor of Streamlining Generic Drug Approvals

San Diego? biotech community is standing behind one of two competing measures that would establish government approval of generic biotech drugs, despite the possible loss of profits by opening up the marketplace to generic competition.

A move to establish FDA processes for generic drug approval could pave the way for patients to receive cheaper versions of high-priced biologic drugs and, possibly, save taxpayers and insurers billions of dollars.

Currently, the United States does not have a streamlined approval pathway for copies of patented biotech drugs, made from living cells, also known as follow-on biologics or biosimilars.

As its stands today, generic biotech drug makers must go through the same expensive and time-consuming clinical trials process as traditional biotechs.

?ive years ago, people were saying this can? be done, it? going to ruin the industry,?said David Gollaher, president and chief executive of the California Healthcare Institute, a local life sciences trade group representing 250 member organizations. ?he industry now sees this as an inevitable part of its evolution and is concerned about the specifics of the products.?

CHI is among the many groups backing a measure that would give drug makers a minimum of 12 years of market exclusivity before generic versions hit the market. Last week, the state stem cell agency put its support behind the proposal, known as the Pathway for Biosimilars Act, or H.R. 1548. Rep. Anna Eshoo, D-Calif., introduced the bill March 17.

Representatives of local trade groups say supporting proposed legislation to remove barriers to entry for generic drugs allows them a say in crafting their future.

? think there? a broad consensus we need to move to the next phase and create an appropriate pathway for an approval of these products,?Gollaher said.


Potential For Losses

Generic competition could cripple profits for drug makers that can spend more than a decade and millions of dollars testing their drugs before they reach the market. Biotech drugs are costly to make and more difficult to produce compared with their chemical counterparts.

San Diego, home to 600 life sciences companies that pump $9 billion annually into the economy, has an inherent stake in the debate.

Several companies, including diabetes drug maker Amylin Pharmaceuticals and Genentech, which makes its best-selling cancer drug Avastin in Oceanside, already have drugs on the market that bring in billions of dollars a year.

Biotechs argue that Congress can? make it too easy for generic competitors to introduce new products because it could discourage innovators from investing billions of dollars into new therapies.

?e can? have generics if you don? have innovators,?said Duane Roth, CEO of San Diego-based trade group Connect.

Unlike traditional pharmaceutical drugs, ?here? much more risk capital involved in the (biotech) industry,?said Jim Hollingshead, a principal with Deloitte Consulting.

Lawmakers, he said, will need to consider more than just data exclusivity before contemplating any changes to today? regulatory process.

A competing bill by Rep. Henry Waxman, D-Calif., that calls for five years of market exclusivity, similar to the existing regulatory scheme for approving traditional chemical drugs, leaves the details of the approval process up to the FDA.


Accelerated Market Reach

Supporters contend that the bill allows generic drugs to reach the marketplace faster, potentially saving more money.

Best-selling drugs such as Genentech? Avastin can cost as much as $100,000 for a year? supply. A recent study by Harvard University found that half of all personal bankruptcy filings were partly the result of medical expenses.

In contrast, Eshoo? bill requires generic drug companies to conduct analytical studies proving drug similarity to brand-name treatments.

Biocom, a life sciences advocate representing 570 companies in San Diego and Orange County, declared support for Eshoo? bill in late March.

?t was evident the approach Congress wanted to take would provide limited or no exclusivity,?said Joe Panetta, president and CEO of Biocom. ?o that? why we began to talk to Anna Eshoo.?

It is unclear exactly what kind of savings a generic biologic could produce.

?n some ways, we wonder if there? a false promise there if generic producers are going to be able to produce something at a much cheaper price,?Panetta said.

But reducing the price of costly biotech drugs has become a part of the hotly contested debate over health care reform.

Industry representatives said they expect pressures from insurers, patient advocate groups and governments to move legislation forward this year.

?? not seeing any major obstacles,?Gollaher said.

-Advertisement-

Featured Articles

-Advertisement-
-Advertisement-

Related Articles

-Advertisement-
-Advertisement-
-Advertisement-