* FDA gives glimpse of biosimilar approval process
* No "one size fits all" approach, FDA says
* Must evaluate "totality of evidence" for biotech copies
* FDA to release final guidance on biosimilars this year
By Anna Yukhananov
WASHINGTON, Aug 3 Evaluating generic versions
of complex biotechnology medicines will require a new, more
rigorous review process, U.S. drug regulators said, in the
first glimpse of their thinking on the subject.
Drugmakers, investors and others have been clamoring for
more insight into the approval process for cheaper versions of
biotech drugs, known as "biosimilars" -- a potentially
multibillion dollar market.
In an article in this week's New England Journal of
Medicine made public on Wednesday, officials from the U.S. Food
and Drug Administration said the approval for biosimilars "will
require a new paradigm of sponsor-FDA interactions," involving
analysis of much more data than traditional generics.
Unlike conventional chemical-based drug compounds, biotech
drugs are derived from living organisms, such as proteins, and
often produced using recombinant DNA technologies.
Tiny differences in manufacturing mean biological drugs are
impossible to replicate exactly, leaving regulators with the
task of deciding just "how similar is similar enough," when
looking at copycat versions of already-approved medicines.
"Given the complex nature of biologics, it's unlikely that
a 'one size fits all' systematic assessment of biosimilarity
can be developed," FDA officials, including the head of its
drugs center, Janet Woodcock, said in the article.
Approval guidelines are likely to be product-specific and
all-encompassing, examining the "totality of evidence"
available about a particular class of biotech drugs.
Speaking directly to the medical community, the FDA said it
may have to review everything from the specific populations
targeted by drugs and the process by which they are made.
Only then will the FDA suggest what clinical trials
companies should conduct to verify any remaining doubts about
safety or efficacy.
"The FDA is currently considering how such interactions
(with companies) might be structured and how they will affect
the user-fee program that Congress has mandated for
biosimilars," the FDA said, referring to industry fees that
drugmakers pay to help cover the costs of drug reviews.
FINDING THE FINGERPRINT
Many drugmakers await the market for biosimilars, including
traditional generic manufacturers such as Israel's Teva
Pharmaceuticals TEVA.O, makers of branded biotech drugs like
Amgen (AMGN.O) and Roche ROG.VX, and other big pharma companies,
including Pfizer (PFE.N) and Novartis NOVN.VX.
The market will range from relatively simple molecules like
insulin to far more complex anti-cancer antibody medicines,
growing to $3.7 billion by 2015 from just $243 million in 2010,
according to a report from market analysis firm Datamonitor.
In 2009, Congress asked the FDA to develop a faster pathway
for approving biosimilars to reduce the cost of biotech drugs. The
agency plans to issue guidance this year. [ID:nN09164934]
Regulatory oversight of generic versions of traditional
pills and capsules has been in place for decades. They are
relatively easy to replicate and prove equivalence to branded
Agreement on a pathway for producing cheaper versions of
biotech drugs -- which treat diseases like cancer, arthritis
and multiple sclerosis -- has been far more difficult because
of their complex manufacturing process.
Making biotech copies is also more costly, as manufacturers
must conduct extra clinical trials to show the new version is
as good as the old one.
However, new technologies that can more accurately describe
the unique "fingerprint" of a biotech medicine can help more
easily compare it to a copycat version, FDA officials said.
While this "fingerprint" technology is in its early stages,
extra animal and clinical trials will still be required "for
the foreseeable future," the officials wrote.
Some biosimilars are already available in Europe, including
versions of Amgen Inc's anemia drug Epogen, and companies are
launching partnerships. [ID:nL6E7HL0HB]
The European Medicines Agency (EMA) published guidelines
for biosimilars in 2005, and approved the first such drug in
2006. FDA officials said they are studying European
regulations, and will likely follow the EMA's approach of
product-specific requirements for different biosimilars.
Despite the FDA's efforts to develop guidelines, other U.S.
regulations may discourage some biosimilar makers by giving
more protection to branded biotech therapies.
Under the U.S. healthcare law passed last year, brand-name
biologic drugs -- which can carry annual price tags in the tens
of thousands of dollars -- were granted a 12-year period of
market exclusivity before generic versions can be sold.
Some potential biosimilar producers may prefer to alter an
existing molecule to improve efficacy or safety, turning it
into a new drug in the eyes of the FDA and securing an
additional 12-year exclusivity.
(Editing by Michele Gershberg, Phil Berlowitz)