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Asian Journal of Biomedical and Pharmaceutical Sciences | Volume 8
May 14-15, 2018 | Montreal, Canada
Global Summit on
Biopharma & Biotherapeutics
M
onoclonal antibodies (mAbormoAb) are antibodies that
are made by identical immune cells that are all clones
of a unique parent cell. Monoclonal antibodies can have
monovalent affinity, in that they bind to the same epitope (the
part of an antigen that is recognized by the antibody). Given
almost any substance, it is possible to produce monoclonal
antibodies that specifically bind to that substance; they
can then serve to detect or purify that substance. This
has become an important tool in biochemistry, molecular
biology, and medicine. In particular, mAbs have been used in
various diagnostic tests, anti-cancer and anti-viral-therapies,
and autoimmune therapies, such as rheumatoid arthritis,
Crohn’s Disease, Ulcerative Colitis, and to help prevent acute
rejection of transplanted organs, such as kidneys transplants,
as well as treatments for moderate-to-severe allergic
asthma. Biosimilar antibodies are highly similar versions
of “innovator” (or “originator”) antibodies with the same
amino acid sequence but produced from different clones
and manufacturing processes. As a consequence, biosimilar
mAbs may include possible differences in glycosylation and
other microvariations such as charge variants that may
affect quality, safety and potency. Biosimilars may also
be follow-on biologics and can also refer to second- and
third- generation antibodies, which may have enhanced
properties, such as greater affinity or longer action, often
referred to as “biobetters”. In contrast to the low-cost generic
versions of small molecules that are off patent, it is currently
not possible to produce exact copies of large proteins and
glycoproteins, such as antibodies, owing to their structural
complexity. Nevertheless, tremendous progress has been
made in bioproduction and analytical sciences, and it is now
possible to produce proteins and glycoproteins that are
highly similar to reference products with little or no clinically-
meaningful differences. The European Medicines Agency
pioneered the regulatory framework for approval of these
products, and now the US and most regulatory authorities
have regulatory processes for the approval of biosimilar
mAbs. The US Food and Drug Administration is one of the
few regulatory authorities that has a regulatory pathway for
biosimilars that are interchangeable, meaning that additional
studies have been conducted supporting that they may
be substituted for the reference product by a pharmacist
without the intervention of the health care provider who
prescribed the reference product. FDA recently published
guidance explaining the additional studies that would need
to be conducted to support approval of an interchangeable
biosimilar. This presentation will look at principally the EMA
and US approaches to regulating biosimilar mAbs including
interchangeable biosimilar mAbs and biobetter mAbs. The
development of legal and regulatory pathways for biosimilars
mAbs will continue to raise much debate among lawmakers,
regulators, originator and generic industry, patent attorneys,
academia and health care professionals.
e:
brian.malkin@arentfox.comRegulatory strategies and considerations inmonoclonal antibody R&D including biosimilars/biobetters
Brian Malkin
Arent Fox LLP, USA