According to research compiled by Reports and Data, in 2018 the global biologics market was valued at over $250 million, but is projected to reach an estimated $625 million by the end of 2026 with an 11.9% compound annual growth rate (CAGR).
Biologics are medications made up of proteins, sugars, or DNA, and oftentimes are a complex combination of these materials and by-products. Biologics can also be composed of living cells and tissues and come in a wide variety of products such as allergy medicines, vaccines, oncology treatments, therapeutics, amongst others.
For example, biologics that employ gene-based technologies are currently leading the charge in biomedical research as the need increases to not only cure serious medical conditions but prevent them from occurring in the first place.
Industry leaders believe that within the next five years, as far as worldwide investment and spending go, 7 out of 10 medicines will be biologics. Existing under the same umbrella of biologics are biosimilars and biobetters. Let’s find out more about what those two terms mean, what sets them apart, and the role they play in the future of biotech and the pharmaceutical industry.
First things first…
What are Biosimilars? – Biosimilars are drugs that are similar to already-approved biologics. As with any biological medicine, biosimilars are put through the same rigorous testing standards that are required to ensure that the pharmaceutical in question is safe and effective. Although some have gone as far as describing biosimilars as a generic version of the reference product, that isn’t entirely accurate. There are important differences between traditional small molecule ‘generic’ medications and their biosimilar counterparts.
What are Biobetters? – There is a new class of biologics that have entered the market known as ‘biobetters’. As the name suggests, biobetters are considered the better, new-and-improved version of existing biologics. Biobetters are altered to include molecular or chemical modifications to improve safety, enhance efficacy, and even reduce toxicity. The NIH offers a more detailed and technical definition of a biobetter, “Biobetters are new drugs designed from existing peptide or protein-based therapeutics by improving their properties such as affinity and selectivity for the target epitope, and stability against degradation.”
Difference Between Biobetters and Biosimilars
Both biobetters and biosimilars are considered follow-on biologics. Meaning they are developed and manufactured in reference to an originator biologic. Also known as biosuperiors, biobetters are an improved adaptation of the originator biologic, while biosimilars aim to mimic the structure of the originator biologic.
A biosimilar, by definition, is used as a regulatory term. Whereas a biobetter doesn’t have any globally accepted definition. While it is currently impossible to precisely replicate an existing biopharmaceutical, biosimilars are as close as you can get to a carbon copy of the reference product. Even though biosimilars are very ‘similar’ to the reference product, it is important to reiterate that they are not duplicates of the originating biologic.
For regulatory reasons, biosimilars are required to have the same dosage form, strength, mechanism of action and route of administration as the existing biologic or reference product. Although, unlike generic medicines, where the active ingredients are identical to the reference product, biosimilars may employ a different manufacturing process and are permitted to contain minor variations in clinically inactive components.
While biosimilars enjoy a speedy FDA approval process, biobetters are evaluated and tested as a new drug because they differ significantly from the reference product. Their formulation has been intentionally modified to improve the drug for a variety of reasons such as efficacy, safety and performance.
When is a Biosimilar not a Biosimilar?
Here are two examples of when a ‘copy’ of the reference product or original biologic is NOT considered a biosimilar.
- When countries that don’t have established regulatory processes or strict evaluation guidelines produce biomimics, or intended copies of a pharmaceutical, these products are not classified as a true biosimilar due to the vacancy of a formal process being in place at the time of production.
- When a biologic has already gone through the manufacturing process but then undergoes a planned change, such as the implementation of new equipment in the production process of scaling, regulatory authorities like the FDA require added comparability exercises to identify any fluctuations in the level of quality, safety and efficacy.
The Future of Biosimilars and Biobetters
With new drugs hitting the market daily, there is a vested interest among pharmaceutical and biotech companies, as well as scientists and physicians to consistently improve upon existing biologics. Considering how lucrative the pharmaceutical industry is, what will related industries choose to pursue when it comes to biobetters and biosimilars?
When it comes to biosimilars, the European Medicines Agency (EMA) was one of the first reputable institutions to provide regulatory guidance on a legal basis for the development of biosimilars. These documents and guidelines have evolved to provide the highest level of standards when it comes to the development of biosimilar medicines throughout the European Union (EU). In the United States, the FDA has implemented its own high level of standards and a strict approval process when it comes to biosimilars.
Biosimilars seemed like a great solution to the soaring costs of new and up-and-coming pharmaceuticals and biobetters. The worry was, and still is in some instances, that new biologics and pharmaceuticals were becoming increasingly expensive, leaving the patient financially responsible to absorb the cost.
Another perk of expanding the development of biosimilars is that they act as innovators, urging other manufacturers to focus on innovation rather than just sticking to established money-makers. But even when you factor in the savings biosimilars offer, which is really important, they still face major obstacles.
There is still much to be discovered when it comes to biosimilars and biobetters, which leads to some uncertainty among physicians and patients with regards to efficacy and safety. Another hurdle in the United States is the broad IP and patent laws, which can impact patient access, increase costs, and create marketing restrictions.
Insurance premiums and payments also pose quite a problem. For instance, if a cancer patient is on an innovator medicine and the insurance company will only agree to cover the cost of the less expensive biosimilar, both the doctor and patient may be urged to change treatment methods even though the innovator drug has proven effective.
But even with all of these roadblocks to contend with, the motivation is there to advance biosimilar and biobetter development and bring revolutionary, life-saving drugs to market. Dr. Lee Schwartzberg, the Chief Medical Director of West Cancer Center in Memphis, says, “It’s possible we will have biosimilars in the realm of antibody-drug conjugates in the next few years.”
Leading Large-Molecule Bioassay & Immunoassay Lab at BioAgilytix
For a more in-depth discussion on biosimilars, we encourage everyone to check out Todd Lester’s webinar, What the New AAPS White Paper Recommends for Immunogenicity Assays Supporting Biosimilars, Part 1. Todd Lester shares details on the AAPS’ recommendation to use a one-assay approach to develop and validate ADA assays supporting biosimilar programs. He also explains how the consensus was reached and explores best practices the paper puts forth. It truly is an illuminating discussion and one that shouldn’t be missed.
BioAgilytix is the world’s leading large-molecule bioassay lab. We provide the specialized large molecule insight and proven GLP / GMP knowledge needed to support a full range of cell-based assay requirements. Our veteran team possesses expertise with primary cells and transformed cell lines. Working with our customers, we are able to develop and validate custom cell-based assays in line with all relevant regulatory guidelines and recommendations.
BioAgilytix is the clear choice for cell-based assay and immunoassay development and analysis. We provide accuracy, reliability and world-class expertise. Contact BioAgilytix today for more information on our wide range of bioanalysis services.