he emerging field of Biosimilars requires some adaptation from the relevant healthcare practitioners, as these complex molecules seem to defy the known facts related to simple chemical entities. Find out why.

1. Change your mindset – on
Biosimilars and Generics
The emerging field of Biosimilars requires some adaptation
from the relevant healthcare practitioners, as these complex
molecules seem to defy the known facts related to simple
chemical entities.
Graeser Associates International

2. “It is not the strongest of the species that survives, nor the most
intelligent that survives. It is the one that is the most adaptable to
change,” said Charles Darwin, and indeed nowhere else is there a
better example of slow adaptation like the one we are witnessing
these days with the penetration of generic biological drugs, or
biosimilars, into the medical world.
The struggle of the regulatory authorities to define the
requirements for approval, and the lagging adaptation of medical
staffs around the world to recognize and comprehend the fact that
we are now facing a brand new class of drugs, makes biosimilars
very intriguing.

3. • Biological drugs, also referred to as biologics, are proteins
which are designed to either mimic or antagonize endogenous
processes, a fact which makes them highly efficient in treating
many medical conditions. The structure of a protein is by far
more complex than that of a relatively simple chemical
molecule.
• Proteins, being constructed of amino acids, have four levels of
structure complexity which include not only the sequence of
the acids and the length of the chain, but also secondary,
tertiary and quaternary folding structures. Comparing a simple
drug like Aspirin (21 atoms) to an average IgG Antibody
(~25,000 atoms), is like comparing the structure and
mechanism of a bicycle to the complexity of a jet plane. It is
thus understood why, unlike chemical molecules which may be
synthesized in a lab by performing chemical reactions,
biological drugs are produced using live cells.

4. • Because of this ability to produce exact copies of chemical
molecules, in the pharmaceutical world we are accustomed to
seeing generic drugs flooding the market once the patent for an
innovative molecule expires. However, in the biological arena,
producing an identical biological copy when the patent for the
original expires is almost impossible since the manufacturing
conditions have to be identical to yield an exact copy of the
protein (as previously mentioned, it is not enough to have the
correct sequence of amino acids, as the folding structures and
post-translational modifications are also crucial).
• That is why follow-on biologics are referred to as
“Biosimilars”, taking into consideration that although similar,
they are not identical. It is essential to understand that the days
of interchangeability of medications, and simple comparative
studies are probably over, and unlike chemical generics, the
safety and efficacy of each new biosimilar will most likely
need to be determined on an individual level.

5. • In our next blog posts, Graeser Associates International will be
exploring the challenges which await the healthcare
practitioners with regard to biosimilars.
• We will also be providing powerpoint presentations, written
reports, and short audio and video presentations through our
Slideshare channel. We will also be selling more detailed
reports and longer audio and video presentations – please see
our biosimilars product page for a list of products
(www.biosimilar.me).

6. • Adv. Ariel Averbuch, RPh, is an advisor on
IP, healthcare and business strategies at
Graeser Associates International (GAI), an
international health care intellectual property
firm, and acts as Chairman at the
Pharmaceutical Society of Israel (PSI). Adv.
Averbuch has been a pharmacist for over 10
years and is also a lawyer and a patent
attorney (Israel), having extensive experience
in the pharmaceutical field. Follow Ariel
Averbuch on LinkedIn and Twitter:
@ArielAverbuch. Follow our biosimilar
communications on Twitter:
@biosimilarsGAI. Email us at
biosimilars@gai-ip.com.