Oct 20, 2022
5 minutes read
Maintaining an influential role in the life sciences industry requires comprehensive knowledge of both biologics and biosimilars, along with their respective market share. Additionally, biosimilar job opportunities are expected to increase, granting aspiring life science professionals opportunities to join an expanding industry. Preparing for this evolving biologics and biosimilars segment of the industry requires establishing yourself as an expert and standing out among your peers. To meet a missing demand, ACMA (Accreditation Council for Medical Affairs) has developed a Board Certified Biologics and Biosimilars Specialist (BCBBS) program.
For life science organizations, upskilling an entire medical affairs team through a biologics and biosimilar education ensures the organization's members have the same level of knowledge and collaborate effectively. As a result of the demand for biosimilars and advances in R&D, the market for biosimilars will continue to accelerate. However, biosimilars face barriers, including provider hesitation and payer incentives for originator products. The Biologics and Biosimilars Specialist Program provides insight into these obstacles for biosimilars, among other topics.
The ACMA’s Biologics and Biosimilars Specialist Program includes the following topics:
Biologics are medications containing biological products derived from living sources such as bacteria, yeast, and animal cells. Biosimilars are also medications containing biological products but biosimilars use are ference product (originator biologic) as a template to create the new biosimilar. Since biologics and biosimilars contain biological compounds, each batch has inherent variations. However, biosimilars are “highly similar” and clinically equivalent to their originator drug.
The following are types of biologics and biosimilars:
In 2010, the Biologics Price Competition and Innovation Act (BPCIA) granted 12 years of market exclusivity for biologics and established an abbreviated pathway to FDA approval for biosimilars under section 351(k).1 However, pharmaceutical companies have created “patent thickets”(overlapping patents), which blocked biosimilars' entry into the market.
On March 6, 2015, Zarxio® (filgrastim-sndz) became the first biosimilar approved in the U.S.4 Many providers have recently been faced with prescribing biosimilars for the first time, leading to uncertainty and increasing demand for biosimilar education aimed at providers.
The blockbuster drug, Humira® (adalimumab), is at the center of multiple patent lawsuits. In 2021, Humira® ranked second in U.S. sales with $20.7 billion. Humira® launched in 2003 and, over the years, has expanded its indication from rheumatoid arthritis to include other diseases such as psoriasis, Crohn's disease, and ulcerative colitis.3 Abbvie, the manufacturer of Humira®, recently won an antitrust case in August 2022, with the judge citing that the 132 patents Abbvie created were not unlawful.
Another milestone for Humira® is the United States Food and Drug Administration's (FDA) approval of Cyltezo (adalimumab biosimilar), the first interchangeable biosimilar to Humira®, in October of 2021. The interchangeable designation requires additional paperwork and studies for regulatory approval, but this status allows pharmacists to make substitutions between the originator biologic and the biosimilar without approval from the prescriber. The interchangeable biosimilar designation remains confusing for many prescribers, patients, and pharmacists.
So far, the FDA has approved only three biosimilars as interchangeable. To qualify as an interchangeable biosimilar, trial sponsors must meet additional requirements, including switching studies, demonstrating patients can switch between the reference product and biosimilar without experiencing side effects or loss of efficacy.
In early August 2022,Coherus BioSciences received approval for Cimerli (ranibizumab-eqrn), a biosimilar to Roche's Lucentis, for the treatment of wet age-related macular degeneration. As well as being the second biosimilar approved by the FDA for Lucentis, Cimerli is the first interchangeable biosimilar for any indication approved without a switching study. With this approval, other biosimilar developers may be able to reduce the time to market, potentially improving the speed of biosimilar adoption.
The leading life science organizations developing biosimilars include:
Biosimilar development is driven primarily by smaller companies, while large companies execute marketing. Globally, Novartis is leading the way in available jobs (406) and Amgen led the way in biosimilar filings (see figure below).
Biosimilar Resources
References