Biomedical Engineering Reference
In-Depth Information
produc t t han nothing on one with an inadequate pr ofile due
to desi gn compromises made, which f ai ls to launch or gain
market share. In June 1999, Immunex (now Pfizer) s igned
an agreement w ith Genentech ( now Roche) to gain access
to it s imm unoadhesi n pat ent portfolio for Enbrel, w hi ch
launched i n the U nited Sta testhepreviousyearandis
currently t he top-selling FP. Infringement cases c an take
many years to resol ve—Abbott Laboratories launc hed t he
mAb H umira in 2003, bu t was sued by Johnson & Johnson
for patent infri ngement in 2007 and subsequently or dered
to pay $1.84 billion c ompensat ion, royal tie s, and i nt er es t.
T h e ve r d i c t w a s , h owever, ove r t u r n e d i n F e b r u a r y 2 0 1 1
when the Court of Appeals f ound the underlying pa tent
to be inval id.
Freedom to operate and other s' IP estates a re of rele-
van c e r eg a r d i n g t h e c o s t s o f , o r b l o c k a d e s t o , d evel o p i n g
c e r t a i n p r o d u c t c l a s s e s o r s t r u c t u r e s . H owever, I P a n d
exclusivit y wil l sim ilarl y a lso govern how long an internal
product w ill enjoy a position in the market free from direct
copies. To t hi s extent, novel approaches such as those
empl oyed by various FPs, can allow a dditional layers of
IP to be secured, potentially de laying the launch of com-
peting products, or generating l icensing payments. IP
cl ai ms must be s u ffic ie n tly broa d to c over potenti al com -
peti tion from b ot h a lt ernative FP and non-FP approaches.
D evel o p e r s s h o u l d s t a y aw a r e o f u p c o m i n g c o m p e t i t o r s
bypassing IP that c ould cut s hort a market, and look to
deve lop nex t-ge neration products offering
whole org anisms, a nd these are inherent ly m ore var iabl e
than chem ical synthesis.
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Even when key patents have
ex pi re d, th e p r o du c tio n o f su f ficiently sim ilar product c an
be delayed by trade secrets. As a result of t hese challenges,
the c hara cteristics in term s of e fficacy and safety (includ-
ing i mmunogenicity) of an approve d biosimilar m ay still
d i ffe r s o m ewh a t f r o m t h e o r i g i n a t o r d r u g . We t a k e t h e v i ew
that this wi ll dam pen t he deg ree t o w hi ch biosim ilars
capture market s hare, as physicians and patients may be
apprehensive about switching treatment with an originator
biologic that has substantial safety and efficacy data, for a
biosimil ar with less data and potentially different charac-
t e r i s t i c s . T h e l evel o f e r o s i o n a s s o c i a t e d w i t h b i o s i m i l a r s i s
also ex pected to be distinctly less than for small molecule
drugs due to a l owe r number of e nt rants. The cost of
establishing biosimilar manufacturing capabilities and
m e e t i n g r eg u l a t o r y d e m a n d s i s c o m p a r a t ivel y h i g h , a c t i n g
as a barrier to entry. Furthermore, we ex pect the price
diffe rential between biosimilars a nd their originator coun-
terparts to be ti ght er than o bserve d f or smal l molecul e
brande d drugs. Lastly, for certain ther apeutic areas such
a s o n c o l o g y, t h e l evel o f p a t i e n t a n d p h y s i c i a n s u p p o r t
provided by the branded drug company may also make
it tougher for biosimilars to gain a foothold in the target
market without substantial investment. We believe
that these factors will together limit the degree to which
direct and indirect biosimilar competitors impact the mar-
ket for FPs.
sufficient
advan ta ge s w i th w hi ch to r eta in ma rket s h ar e.
As bi ol ogic products, FPs are l ess impacted by cheaper
copies after patent expiry than small molecule drugs,
which i n t he United States c an typic al ly ex p ec t to s ee
the bulk of sales eroded within 1-2 years of generics
b e c o m i n g avai lab l e . T h e “B i ol og ic s P ric e C o m p et itio n
a n d I n n ovat i o n A c t o f 2009” (BPCIA) legislation g ives
originator biologics a 12-yea r market exclusivi ty period in
the Uni ted States a nd biosimil ars c an therefore only launch
a f t e r t h i s h a s ex p i r e d . T h e r eg u l a t o r y a p p r oval p a t h w a y s
for b iosim ilars are s ti ll i n their infancy i n Europe, w hi le in
the Unit ed States, the FDA has i ndicated it ex pects t o issue
g u i d a n c e o n b i o s i m i l a r a p p r oval r e q u i r e m e n t s i n 2 0 1 1
a n d h a s s t a t e d t h a t t h e l evel o f h u m a n t e s t i n g w i l l d e p e n d
on assessment of how s imilar the biosimilar i s to the
o rig in a to r dr u g [4 5 ]. To d at e, no bi os im ila r ver si on o f
a mAb or FP ha s been approve d
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in Europe or
the
United States.
De mo ns tr at in g c om pa r ab il ity w ith t h e originator bi o -
logic is likely t o be challenging for bi os imilar versions in
many cases. The BPCIA requires there to be no clinically
me aningful di ff er enc es in s a fe ty, pur ity, and potency
between the biosimilar product and the U.S. l icensed
re fe re nce p r oduc t.
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These character is tics c an be critically
a ffe c t e d b y d i ffe r e n c e s i n t h e m anufacturing process. Bio-
logics are c ommonly produced using c ells in culture or
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http://www.bio.org/media/press-release/new-study-shows-rate-drug-
approvals-lower-previously-reported
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