www.biopharminternational.com October 2021 eBook BioPharm International 17
techniques, wh ich enta i ls a focus
on analy tic techniques and the use
of artif icial intelligence or data sci-
ences to enable innovation, as well as
a decrease in regulation, which may be
a precursor to an increasingly unique
biosimilar licencing process."
As already covered, the key dif-
ferences bet ween the UK and EU
guidelines are the need for UK ref-
erence products, the lack of require-
ment for in-vivo studies in animals,
and changes in the requirement for
a comparative eff icacy trial in most
cases, summarizes Marton. "I believe
changes to the requirements on stud-
ies were needed, ref lecting the expe-
riences of MHRA and EU medicine
authorities over the years," she says.
"Similar changes can be expected at
an EU level as a result of legislative
updates under the 'Pharmaceutica l
strategy for Europe' proposal."
FUTURE ADVANCEMENTS
"Over the next period we can expect
t o s e e m o r e bio s i m i l a r s a c c e s s-
i ng Eu rop ea n ma rk ets a s ma rk et
e xc lusiv it y a nd a l most a l l patents
will expire by 2029. But it remains
to be seen how appealing it will be
for manufacturers to start develop-
ing biosimilars," states Marton. "I
hope that legislative changes driven
by the 'Pharmaceutical strateg y for
Europe' will ref lect the experiences
of the authorities up to now and cre-
ate a clearer and more relaxed legisla-
tive framework for biosimilars."
For Manley, there is an expectation
that regulatory scrutiny of biosimilars
should lessen in the long-term in the
UK, as a result of the adjustments to the
regulatory approach being implemented
by MHRA. The EU is unlikely to expe-
rience any drastic change as the biosim-
ilar development program in Europe is
already successful, she adds.
"The rate at which biosimilars are
being approved is increasing, suggest-
ing a bright future for the regulatory
landscape of biosimila rs," Manley
states. "This, along with the general
enthusiasm about the development of
biosimilars, could encourage companies
to invest more strongly in their biosim-
ilar research and manufacturing."
However, new entrants to the bio-
similar manufacturing market will be
faced with existing challenges, such as
establishing comparability and process
validation, Manley continues. "Thus,
in order to encourage more innova-
tion, regulatory approaches may have
to bear [these hurdles] in mind so as
not to stymie the development of new
biosimilar products," she says.
"As more knowledge is generated
on biosimilar products, and more data
from patients becomes available, more
conf idence will be gained from the
long-term use of biosimilars," declares
Lanucara. " This [increased k nowl-
edge] will hopefully result in a more
standardized approach to the defini-
tion of the core of quality, safety, and
eff icacy aspects for each biosimilar
product class, thus leading to simpli-
f ied approval pathways and stream-
lined development approaches."
Furthermore, although the cost of
biosimilar manufacturing is high, as
reg u lator y approva ls become more
streamlined, faster, and cost-effective,
there will be an inevitable drive for
more biosimilar medicines to enter
the market, Lancaster notes. With
increased competition, it is expected
that prices would be lowered, help-
ing to reduce costs for healthcare sys-
tems—a huge incentive following the
COVID-19 pandemic, he adds.
"However, while facilitating com-
petition reduces costs for healthcare
systems, the f lip side is potentially
increased price erosion and reduced
prof its. Some generic medicines are
subject to rapid price erosion when
they go off-patent. Although the mar-
ket dynamics with biosimilars are dif-
ferent, the nature of the regulator y
framework clearly has an important
role in ensuring a long-term incentive
to invest in biosimilar medicines."
As more data become available and
cost pressures increase on national
hea lt h ser v ices, t he l ikel ihood of
switching bet ween a biosimilar and
originator product w il l be greater,
states Lancaster. Increased com-
petition could also prompt national
regulators to assess whether switch-
ing patients from one biosimilar to
another should be allowed.
"Regulators will be aware of the
need to balance all of these issues,
and it will be interesting to see how
t he reg u l ator y proce s se s for bio-
similar medicines across the globe
evolve over the next decade," con-
cludes Lancaster.
REFERENCES
1. PharmaLex, "EMA Guidance on
Biosimilars in the EU," Press Release,
Nov. 25, 2019.
2. GaBi Online, "Biosimilars Approved
in Europe," Article, Last Updated
Feb. 12, 2021.
3. IMARC, Biosimilar Market in Europe:
Industry Trends, Share, Size, Growth,
Opportunity, and Forecast 2021–2026,
Market Report, May 2021.
4. Vikram, A. Deep, and Manita, Appl.
Clin. Res. Clin. Trials Regul. Aff., 6 (3)
192–211 (2019).
5. EC, Commission Directive 2003/63/
EC of 25 June 2003 Amending
Directive 2001/83/EC of the European
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European Parliament and of the Council
of 31 March 2004 Amending Directive
2001/83/EC on the Community Code
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7. EMA, Guideline on Similar Biological
Medicinal Products, Guidance
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Regulatory Sourcebook Biosimilars
