How Biosimilars Hold the Key to Healing the World?

The word ‘vaccine’ has been used so extensively and frequently these days, that soon-to-be parents fear that it might be the first word, their newborns utter. Though this is just a joke, it does underline the significant role vaccines have played in our life, especially in the Covid-19 pandemic. Be it against polio, hepatitis B, measles or the Ebola virus, vaccines have acted as some sort of panacea. Vaccines, as a sub-group, fall under the overarching group of biologics. Biologics are nothing but drugs which are manufactured using components extracted from biological sources. Human-insulin was the first such bacteria-generated biologic. However, recently, mainly due to the sky-high prices of these biologics, a new form of biologic medical product, known as biosimilar, has been approved for usage.

What are Biosimilars?

The United States Food and Drug Administration (US FDA) defines biosimilar as a biological product which is almost identical to the original product which has been already approved by the US FDA. The medical term for the original product which has been already approved is ‘reference product’. Thus, biosimilar is almost an identical copy of a reference product and has no clinically relevant difference from the reference product. Biosimilar, though an identical copy of the already approved reference product, needs a licensing of its own. In fact, WHO has released its own set of guidelines, called the Guidelines on Evaluation of Similar Biotherapeutic Products , as principles governing approval procedure for biosimilars.

Biosimilars are essentially made using the same initial amino-acidic materials and by using the same processes that their corresponding reference products have undergone. Since, they are of the same strength and dosage, they can be taken in the same way as that of their corresponding biologics. However, biosimilars can be marketed only after the patent of the reference product expires. Also, all biosimilars are prescription drugs and cannot be taken without a healthcare professional’s prescription.

Biosimilars vs. Generic Drugs

A question that naturally arises after knowing about biosimilars is, “Are biosimilars and generic drugs the same?”. The answer is no. Though there are many similarities between biosimilars and generic drugs, they aren’t the same. The basic similarities between the two are:

• Both are manufactured keeping in mind their reference products, and after manufacturing, both are compared with their respective reference products.
• The reference product that is being compared with, in both these cases, should be already approved by the FDA.
• Since the reference product has already undergone several clinical trials, both biosimilars and generic drugs do not need to repeat all the trials. Hence, generally, the procedure followed by biosimilars and generic drugs is shorter in time duration than their reference products.
• Both of them need to undergo approval process, and hence the marketed products of both the categories are safe and effective as their reference counterparts.
• Biosimilars and generic drugs are generally less expensive than original reference drugs.

However, as said earlier, biosimilars differ from generic drugs in a great extent:

• Biosimilars are medical products based on biological sources, while generic drugs have chemical composition. Hence, biosimilars are larger and much more complex molecules which are harder to manufacture. Generic drugs are generally small molecules which are easy for manufacture.
• Though a biosimilar is almost identical to the reference drug, it isn’t an exact copy of the drug. Generic drug, however, is the exact copy of its corresponding reference drug.
• Both of them undergo the mandatory approval process; however, their approval processes are very distinct.
• Even after approval, biosimilars need another approval to be used interchangeably with the reference product. Generic drugs, on the other hand, can be interchangeably used after the first approval itself.

Why are Biosimilars so Popular?

Most importantly, biosimilars offer treatment to varied range of diseases such as cancer, rheumatoid arthritis, diabetes, Crohn’s disease, psoriasis, cardiovascular diseases, hematological diseases, etc. Also, the biosimilars prescribed for these diseases are much cheaper in pricing as compared to their original expensive biologics. Moreover, biosimilars have to undergo rigorous approval process so that they can be approved of their safety standards. As a result of the transparent approval process, biosimilars have, over the years, gained a lot of trust from the medical world with respect to their high standards of efficiency and safety. This rise in popularity and the increasing trust on the biosimilars is boosting their demand. As per a report by Research Dive, the global biosimilar market is expected to rise up to $83,836.40 million in the 2021–2028 timeframe, with a CAGR of 24.90%.

However, even though both the US and European Union have approved biosimilars’ usage, certain apprehensions as to the hurdles in their marketing, remain. Not all biosimilars have provided an economical alternative to their biologic counterparts. Also, the painstaking approval process has, in some cases, unnecessarily tied down many biosimilars in pointless lawsuits. This has discouraged many leading pharmaceutical companies from manufacturing biosimilars, which has eventually affected the patients. Biosimilars have a great potential to offer economical treatment to the needy; some reforms at the research and marketing levels will go a long way in unlocking this potential.

About the Author(s)

Princy A. J

Princy holds a bachelor’s degree in Civil Engineering from the prestigious Tamil Nadu Dr. M.G.R. University at Chennai, India. After a successful academic record, she pursued her passion for writing. A thorough professional and enthusiastic writer, she enjoys writing on various categories and advancements in the global industries. She plays an instrumental role in writing about current updates, news, blogs, and trends.