Change your mindset – on Biosimilars and

Generics

Graeser Associates International

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.

“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.

• 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.

• 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.

• 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).

• 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.