A biological medicine designed to specifically inhibit the parts of the immune system which fuel inflammation can certainly be a fitting answer to the prevention, diagnosis, as well as treatment of a spectrum of chronic illnesses including cancer, chronic kidney disease, autoimmune disorders, and infectious diseases.
These biological medicines exist. They are called biologics.
Biologics are genetically engineered proteins derived from human genes. Below is the process of their production:
1. A target DNA sequence is transferred into a target host cell through a plasmid or viral vector to get the desired protein expression.
2. Only after it is ensured that the transfected host cell can effectively express the protein, the cells are cultured. Large bioreactors under specific, controlled conditions (e.g., growth media, temperature, etc.) are used to grow them at an exponential rate.
3. Once the cells have produced enough quantity of the biologic, it is recovered through a combination of filtration and centrifugation, and finally purified through chromatography.
4. The structure, function, and purity of the final bulk drug must then be fully characterized using analytical techniques.
Aspirin, a common drug, is made of only 21 atoms, while Enbrel, a biologic used to treat rheumatoid arthritis and plaque psoriasis, consists of more than 20,000 atoms
The fact that biologics are synthesized using living systems, accounts for their typically large and complex size, structure, manufacturing, characterization, stability, and immunogenicity when compared to the synthetic small molecule drugs.
As a result of their complex makeup, biologics are highly sensitive to manufacturing and handling conditions. Moreover, their production details are highly-guarded intellectual property of the company that develops the initial drug. Creating copies is, therefore, a difficult task.
A biosimilar is a biologic that is ‘similar’ to an FDA-approved biologic drug, and is made as a ‘follow-on’ or ‘subsequent entry biologic’ by a different company.
“If creating a generic drug is like designing a tricycle (in terms of complexity and size), then a biosimilar is like building a spaceship!” quoted Asthika Goonewardene, a senior healthcare analyst with Bloomberg Intelligence.
Why do we need biosimilars?
- Being officially approved versions of biologics, their production comes handy when the patent of the original product expires.
- Since they aren’t exact imitations, biosimilars are better affordable in comparison to the generic biologics, and are instrumental in treating a range of diseases including cancer, rheumatoid arthritis, diabetes, and anemia.
As the process of biologics’ production is quite heterogeneous, the final product contains a myriad of different components, such as an active biologic with different post-translational modifications to the protein and impurities within the bulk product. However, the pattern of these components should be consistent from lot to lot and must meet specific quality standards as outlined by international FDA standards.
For this reason, biosimilars are far from American shores yet. However, they are fast gaining attention of Pharma companies.
Some Noteworthy Drugs That Spell ‘Revolution’
Hero drug molecules fight the evil forces of diseases, wayward immune systems, and infections. The year witnessed the entry of some new drugs with a highly effective mechanism of action and some old ones which proved their mettle in curing illnesses they weren’t even intended to cure! Read More..