Biosimilars, a Pharmacist’s perspective

Graeser Associates International

Not many things can profoundly affect and perhaps even alter a profession, let alone the pharmacist’s profession.

However, biosimilars might do just that

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.

• 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.

• 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.

• 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).

• 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.