FDA realigns to support possible biosimilars change

Image Source: FDA

On August 15, the generics industry stuck a deal with the FDA that could expedite the approval process of generic drugs after fees are paid.  It is believed that first year fees could reach up to $299 million to speed up the review process which typically takes 2 1/2 years currently for approval.

The FDA Office of Generic Drugs has reported they are adding a second Division of Bioequivilance and a fourth Division of Chemistry.  Director Helen Winkle released the plans in a memo from the Office of Pharmaceutical Science.  According to Cutting Edge Information, they believe that the addition of a second Division of Bioequivilence could indicate that there has been an agreement reached after the initial Biologics Price Competition and Innovation Act passed Congress in 2009.

The Business of Biosimilars and Biobetters Conference will be addressing the abbreviated pathway  head on, with a panel of experts examining the pros and cons of paying for expediting the process of the approval of generics.

How do you feel about paying to expedite the review process?

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What's next for the Pharma industry?

The Atlantic has a very interesting article looking at the future of the Pharma industry. With most of the patents set to expire at the end of next year, many companies are also facing pipelines with few products and low approval rates from the FDA. With the clinical trials being the most expensive parts medical development, in addition to the targets of new drugs being very small portions of the population, many drugs are shelved or are out of financial reach for many of the patients who need to use them.

Pharmaceutical companies are blamed for focusing on marketing at the expense of innovation: they allegedly kill promising compounds because of fears of small markets, then concentrate on “me too” drugs that aren’t really any better than their competition’s. Or they tweak existing drugs in ways that don’t necessarily make the drugs any more effective, but do give companies a new patented drug for which they can charge the Earth.

Read the article here.

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DDP 2010: Interactive Audience Panel & Polling: the Dollars and Sense of Drug Delivery – Facts, Figures and Trends that Impact Product Performance

Josef Bossart, PhD
Managing Director
BioNumbers LLC (Moderator)

Are we going for more difficult products, or are there more rookies in the game? The time for drug approval has significantly increased. DDEP has increased steadily over the years. The FDA is not the problem when it comes to approval times. The median average is about eleven months for FDA approval. If the data is poor, the FDA will send you back. The FDA is not the problem in drug delivery approvals. If you’re a drug development company, you should have 4-6 products in the pipeline in order to get one approved.

Many companies believe that $15 million to the MDA submission. There are $228 million dollars to get products developed in the early 1990s. Now that coast for DDEP is about $85 millions. The direct cost when risk is adjusted is $160 millions.

Key numbers:
Data Points – In a study of drug development, Bossart found that one in six Pharma products that start in the market get approved.

There are a total of 197 DDEP have been approved in the period of 2000-2009, an average of 20 per year. The top year for approvals was 2007 with 28 DDEP approved by the FDA.

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Should the FDA be sharing more about clinical trials?

According to the LA Times, the FDA could be providing more information about approved drugs with doctors and the public. While most of the information doctors use to prescribe medicine and information patients use to learn about the medicine, there's a lot of information that is left out about the drugs. The article points out a few cases in which the FDA doesn't share some of the road bumps that occurred in Phase III clinical trials, such as the drug being ineffective in some of the population.

What do you think? I think that the FDA should share all of the information they possibly can on a drug, and how the drug was accepted by different people's systems. If a drug barley passed the FDA approval, they should be required to share that too, as it could help doctors when prescribing it to individuals. Read the full article here.

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