This document discusses how biosimilars may profoundly impact the role of pharmacists. Biosimilars are similar but not identical to biologic drugs, and slight manufacturing differences can impact a biosimilar's effects. This requires pharmacists to refrain from automatically substituting biosimilars and become more familiar with their potential side effects and immunogenic responses. The document also notes that future posts will explore challenges for hospital pharmacists providing biosimilars and provide additional educational resources on biosimilars.

1. Biosimilars, a Pharmacist’s
perspective
Not many things can profoundly affect and perhaps even
alter a profession, let alone the pharmacist’s profession.
However, biosimilars might do just that
Graeser Associates International

2. The pharmacist, being an integrated member of the health care
team, is focused on providing consultation and promoting safe and
effective medication use. Specifically, the hospital pharmacist has a
crucial role in providing accurate information about drugs to both
the patient and other members of the medical team. From detailed
mechanisms of action to rare side-effects, the pharmacist has to
keep up with the constantly updating, abundant information the
pharmaceutical field has to offer.

3. • However, being familiarized with the activity of relatively
simple chemical entities is entirely different from profoundly
understanding the complex world of biological drugs, and that
is where the biosimilars kick in. Biosimilars, or follow-on
biologics, are the closest thing to generic versions of biological
drugs.
• But unlike the simple chemical molecules which may by
synthesized in a lab in many different ways, biological drugs
are manufactured using live cells, and thus, even slight
modifications in the process conditions may yield a
considerably different biological drug. From a regulatory point
of view, biosimilars are approved in reference to the originator
biological drug and are required to undergo a process of
approval in order to ensure that they are sufficiently similar to
the reference product in order to be safe and effective.

4. • Accordingly, the pharmacist is now required to refrain from
taking issues like interchangeability for granted, as switching
one biological drug for another, even if having the same
“generic” name, may cause the patient to react differently. In
fact, some regulatory authorities around the world, including
the US, Canada, Europe and Israel have expressed their
concerns about the interchangeability of biologics by
pharmacists. The pharmacist is also required to get
familiarized with side effects and possible complications of
biological treatments, such as systemic immunogenic
responses, which are less common with simple chemical
molecules.

5. • In our next blog posts, Graeser Associates International will be
exploring the challenges that are facing the hospital
pharmacists, who will be at the front line of much of the
uncertainty for providing biosimilars to patients.
• We will also be providing powerpoint presentations, written
reports, and short audio and video presentations through this
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.