1. Biosimilars in
Israel, where do we stand?
Leading or lagging? When it comes to the adaptation of
interchangeability aspects of biosimilars you are either
ahead or behind. Where does Israel stand?
Graeser Associates International

2. These are times of uncertainty, when new biological drugs
penetrate the market, yet regulatory authorities have a hard time
making clear cut decisions. One highly debatable subject is the
matter of interchangeability of innovative biologics and biosimilar
drugs. The problem arises since the biosimilar is not identical to the
reference product, and as such, switching between the two might
cause serious side effects and immunogenic responses for the
patient.

3. • Until recently, the Israeli Ministry of Health (MOH) did not
issue clear guidelines with respect to the interchangeability of
biologics and biosimilars. Accordingly, the Pharmaceutical
Society of Israel (PSI), being the largest pharmacists’
organization in Israel, was concerned with the possible liability
of the dispensing pharmacist in case of a possible adverse
reaction due to a switch between an innovative biological drug
and a biosimilar.
• On April 30, 2012 the PSI raised its concerns with the
MOH, stating that without clear guidelines the biosimilars are
regarded as generics, which does not seem to be the proper
definition for these follow-on biologics. On 21 June 2012, the
MOH issued a brief notice stating that although there is room
for interpretation of the law when it comes to generics, unless
otherwise stated, interchangeability of biosimilars is allowed.

4. • It didn’t take long for the MOH to change its mind, and on 2
August 2012, the MOH issued a second notice overturning the
previous guidelines, and now stating that although possessing
an active ingredient bearing an identical name, the biosimilars
are in fact not identical to the reference product. As such, the
MOH determined that the pharmacist is not allowed to switch
between a biosimilar and the reference product and vice
versa, without explicit directions from the physician. The
MOH also added that a special committee will be appointed to
determine the possible interchangeability options for specific
biosimilars on a case by case basis.

5. • In our next blog posts, Graeser Associates International will be
exploring the challenges that are facing the healthcare
teams, having to face much of the uncertainty upon providing
biosimilars to patients.
• We will also be providing powerpoint presentations, written
reports, and short audio and video presentations through our
Slideshare channel (www.slideshare.net/biosimilars). 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.biosimilars.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.