[Ip-health] Pharmatimes: US Congress urged to act on biosimilars

[Sarah Rimmington]

http://www.pharmatimes.com/WorldNews/article.aspx?id=3D16673

US Congress urged to act on biosimilars

01 October 2009

US campaigners yesterday urged Congress to create a =93real=94 regulatory
pathway for generic versions of biologic drugs, but researchers warn that
it may take until 2011 to implement any such policies.

Current proposals for a regulatory pathway for generic biologics - also
known as biosimilars, biogenerics or follow-on biologics - in Senate and
House healthcare reform bills will actually block production of most
generic biologics, but if these are improved in critical ways they could
save $71 billion or more in the first decade alone, say the consumer and
medical student groups which are leading the campaign.

The proposals, originating from Representative Anna Eshoo House bill HS
1548 and past bills in the Senate, would provide 12 years=92 market
exclusivity for biosimilars compared to five years for other drugs.
However, the campaigners point out, the Pharmaceutical Research and
Manufacturers of America (PhRMA) puts development costs for biologics at
$1.2 billion, close to that for conventional drugs at $1.318 billion, and
that the Federal Trade Commission (FTC) recommends zero years market or
data exclusivity for biologics, given that biosimilars will cost more to
bring to market for generic manufacturers than conventional generics,
leaving originator companies with 70%-90% of the market.

These proposals will also allow =93evergreening,=94 whereby pharmaceutical
companies will be allowed additional 12-year periods of exclusivity for
=93relatively inexpensive minor tweaks=94 which, they say, could block
price-lowering generic competition indefinitely.

The language in these bills creates biologic drug monopolies, which
discourage innovation and raise costs for the US health system, say the
campaigners. However, they add that these problems can be addressed by
adopted the relevant sections of bills introduced by Representative Henry
Waxman (HR 1427) and Senator Charles Schumer (S 726), which would allow
five years=92 exclusivity and block evergreening.

Biologics are the fastest-growing segment of the drug market, are
predicted to be 50% of new drug approvals soon and include most vaccines
and treatments for cancer, multiple sclerosis and rheumatoid arthritis.
Already, the top six biologics make up over 40% of expenditures for the
Medicare prescription drug programme, the campaigners add.

Meantime, researchers in the current issue of the British Medical Journal
(BMJ, September 19, vol 339) warn that =93unless biological therapies can b=
e
made more affordable, western health care systems face a financial
crisis.=94

Demand for biologic therapies is enormous, clinicians are prescribing them
at increasing rates and pressure is growing to use them earlier in disease
progression, say the authors, consultant physician Fraz Mir and student
Christopher Kelly of Addenbrooke=92s Hospital in Cambridge, UK. However,
they add that potential generic manufacturers face a number of major
hurdles, not least the fact that development of a biosimilar costs about
=A3120 million compared to =A31-=A32.5 million for a small-molecule generic=
.
Moreover, while US President Barack Obama=92s first budget in February
included proposals for an abbreviated regulatory pathway for biosimilars,
it may take until 2011 for the Food and Drug Administration (FDA) to
implement any new policies, they suggest.

- The global market for biosimilars is expected to be worth US$19.4
billion by 2014, increasing at an average annual rate of 89.1% from 2009,
according to a new report from Marketsandmarkets,

By Lynne Taylor