Why are Medical Sector Businesses Increasingly Focusing on Biosimilar Testing and Development Services?

Key takeaways:

• Introduction
• Importance of biosimilar testing and development services
• Influential factors impacting the growth of the sector in North America

The ultimate aim of any research, technological advancement, or innovation in the medical and healthcare sector is to improve the efficiency and quality of diagnostics, treatment, and rehabilitation services. The innovation of biosimilars and biologics is an example of this; a biosimilar is a biological medical drug that is identical to the original drug in its composition and effect. Just like generic drugs, biosimilars can be manufactured only after the patent of the original drug expires. Also, biosimilar manufacturing companies have to get approval from the regulator before starting the production of the drug. The regulator, before approving, conducts tests of the biosimilar drug to ascertain its safety and efficacy.

Analyzing the rising importance of biosimilar testing and development services

Biosimilars are considered identical to generic drugs; however, there are certain differences between the two. While generic drugs have the exact chemical composition of the original drug, biosimilar drugs do not have the exact copy as that of the original biological drug. As a result, the approval process for both these types of medications is quite different. Since generic drugs are exact copies of the original, their approval process is relatively easier as the chemical composition is already tried and tested.

On the other hand, the approval process for biosimilars is quite complex and rigorous. This is because both biologics and biosimilars are made from living systems whose characteristics can change with time and environment. Since biosimilars can have different versions of the living system, they need to be tested thoroughly, if not from scratch. Also, the approval received for a biosimilar cannot be interchanged with the original biologic drug. The level of scrutiny the biosimilar is subjected to depends on how similar the drug is compared to its original biosimilar. For approval, the biosimilar manufacturing company must prove that its product, despite using other living systems, has clinically no meaningful difference from the original reference biologic drug.

Understanding the reasons behind the growing demand for biosimilar testing and development services in North America

The biosimilar testing and development services industry has witnessed tremendous growth across the globe, especially in the North American region. This growth in North America can be attributed to the rise in demand for biologic drugs and biosimilars to treat different kinds of chronic ailments and diseases. Researchers in the US have developed biosimilars for treating cancer; these drugs have even received FDA approval and thus are widely sold in the country. As a result, there is an increased trust in biosimilars which has led to many pharmaceutical companies kickstarting their biosimilar manufacturing operations. The importance and demand for biosimilar testing and development services have further increased.

Another important factor that has positively impacted the growth of this sector is that pharmaceutical firms and biotechnology companies have started outsourcing the services associated with preclinical, clinical, and laboratory testing. This has led to these companies getting access to the latest tools and advanced testing facilities which has improved the quality and efficiency of biosimilar drug testing. Thus, nowadays, pharmaceutical and biotechnology companies are increasingly focusing on research and commercialization of the drug, while contract research organizations and specialized drug testing laboratories test these drugs.

Along with this, countries in North America and Asia-Pacific regions have enacted schemes that promote the use of biosimilars to treat chronic ailments. Furthermore, the patent period of several reputed biologic drugs has expired which have paved the way for pharmaceutical companies to develop biosimilar drugs with an identical composition. As a result, several drug discovery and research companies are launching biosimilar testing services. For instance, in September 2020, Almac Sciences, a leading drug discovery company in the US, announced the launch of biologics testing services that comply with FDA, EMA, and PMDA services.

To sum it up, biosimilars are drugs that have identical, but not exact composition to biologics. Hence, the approval process for these drugs is complex and rigorous as compared to generic drugs. As a result of this, the importance of biosimilar testing and development services has increased across the globe, especially in North America.

For insights into how your business can capitalize on the opportunities offered by the industry, feel free to contact us.

Related Post