
In this era where the demand for affordable healthcare is increasing every day, biosimilars that are replacements for biologics have proved to be a boon. Majority of the complex diseases such as cancer, arthritis, diabetes, etc. require biologics for their treatment which are highly expensive and cannot be afforded by everyone, thus biosimilars which are substitutions to biologics and are less expensive with similar safety and efficacy have helped patients to access many therapies.
What Are Biosimilars?

Biosimilars are similar to biologics already approved by the FDA or EMA which are used in therapies for most diseases such as cancer, arthritis, etc. These are called reference products as they match their reference biological product in terms of structure, function, clinical aspect, etc. These biosimilars just slightly differ in the manufacturing process from the biologics. Biosimilars are cost-effective as they do not undergo the full-scale testing and developmental process as biologics. They are subjected to testing for safety, efficacy, and other aspects but the test data that already exist for biologics can be skipped for biosimilars.
Developmental Process For Biosimilars:

The developmental process of biosimilars undergoes four different steps beginning with research and development where all the analytical parameters of biosimilars are studied, followed by the pre-clinical studies step where the animal study is done, then comes the clinical studies step where human pharmacokinetic and pharmacodynamic data is studied through clinical trials which is then finally accomplished by FDA approval and marketing surveillance step.
Regulatory Framework For Biosimilars:

The biosimilar approval process is regulated by various regulatory bodies worldwide such as the FDA, EU, WHO, etc. These regulatory bodies and their key regulations are discussed in brief below:
FDA:
In the US the approval of biosimilars is managed by the FDA under the Biologics Control Act (BCA). Some of the key regulatory requirements of the FDA are as follows:
The biosimilars should be very similar to the reference biological product in terms of safety, efficacy, and quality.
Only slight differences that do not affect much are acceptable from biosimilars.
Only after receiving a designation called “interchangeable” from the FDA, the biosimilar product can be substituted for a reference product without the intervention of the physician.
FDA required detailed pre-clinical and clinical data for the biosimilar approval
FDA makes it a compulsion to name a biosimilar product with a four-letter suffix to easily distinguish between the biosimilar and biologic products.
For more details regarding the approval process by the FDA for biosimilars visit the FDA's official page.
EU:
In European countries, the EMA under the EU ideas the regulatory frameworks for biosimilar products. The key guidelines by EMA are as follows:
The comparability approach is used by EMA for the approval process of biosimilar product where the biosimilars are compared head-to-head to the reference product.
The biosimilar product’s clinical data should prove its safety, efficacy, and quality through accurate scientific data.
Manufacturers are required to provide data for the manufacturing process for biosimilars to EMA.
EMA does not grant the title of “interchangeable” to biosimilar products as the FDA does.
For more details kindly check, the official page of the EU
WHO:
The international guidelines for the development and approval of biosimilars are provided by the WHO. They do not approve biosimilar products directly but provide a set of standard guidelines for other regulatory bodies. Some of their key points are mentioned below:
The WHO guidelines for biosimilars focus on quality, clinical, and non-clinical data.
It also focuses on assuring analytical testing in terms of safety, efficacy, and purity.
WHO focuses on and promotes post-marketing surveillance.
Other regulatory bodies:
Many other countries have published their guidelines like the FDA and EU guidelines for the approval process of biosimilar products by their regulatory bodies such as CDSCO in India, PMDA in Japan, etc.
Regulatory Challenges In the Biosimilar Development Process:
The process of development of biosimilars faces some regulatory challenges which are as follows:
Developing biosimilar products is the biggest challenge as all the criteria need to be identical to the reference product such as safety, efficacy, quality, etc.
The manufacturing process of biosimilars is difficult as they need to be prepared by living cell cultures, any one mistake in the cell culture conditions may lead to differences from the reference product.
Immunogenicity presents another challenge in the manufacture of biosimilars.
For a biosimilar process to achieve interchangeable positions deep study of clinical data and other aspects is required.
According to the FDA naming rule the biosimilar should have a reference product name with the four-letter suffix, which may pose a thread of mixing of the biosimilar with the reference product due to their similar kinds of names.
For a biosimilar product to get approved in various regions it needs to make amendments in the biosimilar product according to the rules and regulations of the different regions.
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FAQ's:
1. What does biosimilar mean?
A: Biosimilars refer to identical reference biologics that are used in various therapies and are approved by a regulatory body.
2. What are biosimilar drugs?
A: Biosimilar drugs are biological products like biologics which are already approved and are the same in terms of safety and quality.
3. Are biosimilars interchangeable?
A: Not all biosimilars are interchangeable except for those biosimilars that are approved by the FDA for interchange.
4. Are biosimilars the same as generic products?
A: No, biosimilar and generic products are not the same, they differ in terms of composition, developmental process, and regulatory approval.
5. What is biosimilar medication?
A: Biosimilar medications are medications prepared from biosimilar drugs that are the same as biologics in terms of safety, efficacy, and quality.
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