In the United States, Biologics account for 40% of all pharmaceutical spending, however fewer than 2% of Americans use them. What makes them so expensive? Can Biosimilars help solve this problem? Read below to know more.
What are Biologics?
Most medications in your medicine cabinet at home from allergy pills to blood pressure medications are called small molecule drugs. They’re made from chemicals. And you can find them in a variety of dosage forms, including capsules, liquids, and topical creams. In contrast, biologics are made from living sources such as bacteria. They’re mostly available as injections and infusions. Biologics can be remarkably effective in treating a variety of illnesses, ranging from autoimmune diseases to cancer. However they usually come with a high price tag, often in excess of $100K per patient per year.
What are Biosimilars?
Biologics don’t have generics. They have highly similar and less expensive versions called biosimilars. Generic is to brand as Biosimilar is to biologics - sort of. Because of the complex nature of biologics, they are difficult to copy. Since the living cells they originate from are unique, it’s almost impossible to make a drug that acts the exact same way. So, biosimilars are products with similar structure, function, safety, and effectiveness as biologics, but they are not interchangeable with them.
In 1984, Congress passed an accelerated approval pathway for Generics and now generics account for about 90% of all prescriptions in the US and have saved the Healthcare system roughly 1 Trillion dollars between 2002 and 2011. Accordingly, in 2010, Congress passed the Biologics Price Competition and Innovation Act (BPCIA), for an abbreviated pathway for biosimilars to gain approval by the FDA.
Under the BPCIA, the FDA might approve a biosimilar upon a manufacturer’s showing that it is “highly similar” to the reference biologic and, eliminating the need for the biosimilar manufacturer to conduct a full set of pre-approval clinical trials, which are required for the originator drug. However this requires submission of additional data, including results from trials in which patients have switched from the reference biologic to the biosimilar. In most states, obtaining this status would allow pharmacists to substitute a biosimilar for the reference biologic without intervention from the prescribing clinician.
Can Biosimilars provide the much waited affordable healthcare?
Not that easy. Let’s take the case of biosimilars for the most popular biologic ever Humira (adalimumab) from Abbvie. AbbVie procured over 100 patents on the product. Although AbbVie’s active ingredient patent on adalimumab expired in 2016, it was granted a series of patents protecting everything from the manufacturing process to new formulations of the drug that they used to sue competitors for patent infringement. This strategy of creating a wall of patents to protect assets is known as developing a “patent thicket.” After years of legal battle, finally a Biosimilar for Humira is expected to hit the market in 2023.
What is the Solution?
In July 2018, the FDA published its Biosimilars Action Plan, acknowledging the lack of competition in the biologics space. Recognizing the numerous barriers to the development and utilization of biosimilars, the FDA outlined 4 key goals in tackling this issue, including
1️⃣ Streamlining the approval process,
2️⃣ Improving regulatory clarity,
3️⃣ Increasing educational efforts to improve understanding among stakeholders, and
4️⃣ Collaborating with the Federal Trade Commission to address anti competitive behaviors.
🔥 🔥 🔥 Finally Biosimilars have started to gain momentum with $15B global sales in 2020. According to McKinsey’s biosimilars market model, the market is set to continue its double-digit growth, doubling in size to more than $30 billion by 2025, and over $60 billion by the end of the decade. A flourishing biosimilars market could broaden patients’ access to advanced treatments at more affordable prices and alleviate healthcare costs. Payors and providers could use the savings to improve overall patient care.
Subash Rajavel is the founder and Chief editor at xGenom. He has 15 plus years of experience in Health care and Life Sciences. His primary focus are Patient centric solutions, Digital Health and Next-gen Clinical Trial solutions.
You can reach him at subash@xgenom.com
REFERENCES
https://journalofethics.ama-assn.org/article/why-are-biosimilars-not-living-their-promise-us/2019-08
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