Scrip 100 December 2008

POLICY & REGULATION
market issues
medicines association, the GPhA, said it did authorities released draft guidance on what
It is not only scientiﬁ c issues that are
not like the EU’s guideline-based approach, they call “subsequent entry biologics” (SEBs),
hindering the biosimilars sector. According to
and preferred a system that gave the FDA the which would allow approval based on a
the European Generic medicines Association
discretion to decide what data are required similarity exercise versus the originator product.
(EGA), although biosimilars are becoming an
on a case-by-case basis. An SEB would not necessarily have all the
established part of the European regulatory
Arguments are also raging over the length
indications of the reference drug, and clinical
scene, the concept needs to gain wider
of the exclusivity period that should be
trials would be required to show safety,
recognition and acceptance if these products
awarded to innovators in any biosimilars
efﬁ cacy and quality, with the amount and type
legislation. The R&D-based industry has been
are to make real inroads into the market.
of data required depending on the level of
holding out for at least 14 years, while the
The association’s director Greg Perry told
similarity shown between the two products.
GPhA prefers ﬁ ve (the exclusivity period in
an EGA conference in April that a number
The guidance documents said the food
the EU is 10 years).
of hurdles stood in the way, such as efforts
and drug regulations would be amended
So what are the chances of legislation
by innovator companies to hinder the
to lay down a comprehensive legal basis
being passed in the near future? Because of
acceptance of biosimilars among doctors,
for regulating biosimilars, and that in the
the presidential and congressional elections,
pharmacists and patients. He claimed
meantime the guidance itself could allow
any pending legislation will have to be
innovator companies were trying to portray
biosimilar product approval. They did not,
reintroduced in 2009.
biosimilars as somehow less safe or effective
however, make any mention of market
Things have also become more complicated
than the reference products.
exclusivity for originator products.
with the intervention of the Federal Trade
Mr Perry said biosimilar medicines were
In Japan, the regulators are drawing up
Commission. In late August, the FTC said it
manufactured to the same quality standards
formal guidelines, and in the meantime plan
intended to look into the possible competitive
as other biopharmaceuticals and that clinical
to proceed on a case-by-case basis. The ﬁ rst
impacts of implementing a biosimilars approval
efﬁ cacy and safety were demonstrated in
biosimilar to take advantage of this case-by-case
pathway. The FTC has already had to deal
clinical studies. “The use of scare tactics
approach was Japan Chemical Research/Kissei’s
with a number of potential antitrust issues
recombinant EPO for the treatment of anaemia
against biosimilar medicines must cease,” in the area of chemical generic products,
in dialysis patients, which was ﬁ led in November.
he declared. such as patent settlements and authorised
The continuing lack of biosimilars legislation
The European Commission, which is generic deals among originator companies and
in such important markets is a problem because
responsible for approving biosimilars, also generics ﬁ rms.
global companies need global access to patients.
came out in defence of the products. At
The issue was raised again by the EGA’s
the conference, Nicolas Rossignol of the
commission’s pharmaceutical unit said:
Things have also become
Mr Perry at an Information Day organised by
his association and the EMEA in October.
“We have promoted and developed with
more complicated with the
the European Medicines Agency a special
biosimilars framework. So we are conﬁ dent
intervention of the Federal
sustainability
Mr Perry said global biosimilar development
that if a product meets all the requirements Trade Commission
was very important for the sustainability
and gets a marketing authorisation from
of the biosimilars industry. Acceptance of a
the commission, it means that the product
global development programme, he pointed
is as safe and effective as any other product
out, would reduce the number of redundant
authorised by the commission.”
The commission fears that these practices
clinical trials and the consumption of ﬁ nite
might spill over into the biosimilars arena,
seeking global recognition
and is taking action early in order to head
regulatory and industry resources.
Mr Perry said he hoped that eventually
them off. Kurt Karst, an associate of law
For now the generics industry’s dream
companies would be able to submit the same
ﬁ rm Hyman, Phelps & McNamara, said the
of a worldwide marketplace for biosimilars
“global data package” in each country where
FTC had learnt a lot about anticompetitive
remains just that. But if there is sufﬁ cient
approval of a biosimilar was sought. The key
actions under the Hatch-Waxman Act, and
political impetus, some progress might be
word here is “eventually”. Mr Rossignol (who
considered this “a good opportunity to
made in 2009. Attention will focus on the
has since left the commission) said there
wade in early and nip it in the bud” in the
all-important US market, where some have
was no reason in principle why a global data
biosimilars arena.
predicted that a biosimilars pathway could be
package would not be possible. However,
In preparation for a workshop the
in place by 2010.
this would “imply that you have at least an
FTC planned to hold in the autumn, the
There will be strong political backing
commission put out a series of questions for
for such legislation: before his election as
established biosimilars framework in the US,
public comment. These asked, among other
President, Barack Obama said that he saw
with the notion of a reference product. But
things, whether biosimilars should have their
biosimilars as a key component in keeping
for the moment we don’t have that, so there
own marketing exclusivity period and what
down healthcare costs. He was also reported
is a long way to go.”
the likely impact of the interchangeability of
as saying that the legislation should offer as
There is indeed. Despite years of effort,
biosimilars would be.
short an exclusivity period as possible for
and the existence of the EU model, the US
The FTC will collate the responses from
originator drugs. When the long-awaited
still lacks any form of a biosimilars pathway.
the consultation, together with the results of
legislation is ﬁ nally passed, it could well fall
Several bills have been tabled, including the
the workshop, and put them into a report short of what originator companies have
Pathway for Biosimilars Act, the Access to
scheduled for release in spring 2009, which been pressing for.
Life-Saving Medicines Act, and the Patient
will analyse the potential marketplace effects
Protection and Innovative Biologic Medicines
of the various policy options.
Ian Schofi eld is a principal
Act. But none has made much headway.
Progress has been held up mainly by Canada and Japan
analyst for Informa Pharma.
disagreements over questions such as Elsewhere, efforts continued to draw up
interchangeability and whether the US should biosimilars legislation, but again progress has
follow the EU example. The US generic been patchy. In March 2008, the Canadian
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