We at Samsung Bioepis believe a class of interchangeability products may cause misunderstanding and misinterpretation of the scientific rigor that goes into the biosimilar approvals process.
A second class of biosimilars that are considered "interchangeable" could set biosimilars back in terms of acceptance, according to Albert Kim, MBA.
The FDA’s interchangeability designation for biosimilars was intended to improve uptake and acceptance of these agents, but so far it has created misperception and confusion, according to Albert Kim, MBA, vice president of the Commercial Division at Samsung Bioepis, of Incheon, Republic of Korea.
“The intention was to put biosimilars at parity to biological originators,” but in effect, the interchangeability designation has created 2 classes of drugs and may ultimately damage the hard-won acceptance that biosimilars have achieved, Kim said in a recent interview.
Samsung Bioepis is the biopharmaceutical arm of Samsung Group and has 5 biosimilars approved and launched in various global markets: etanercept, infliximab, trastuzumab, bevacizumab, and adalimumab biosimilars. The company also has biosimilar candidates in development for ustekinumab (Stelara), denosumab (Prolia), and eculizumab (Soliris).
The United States vs the European Union
There are no interchangeables approved by the FDA so far; however, Viatris and Boehringer Ingelheim are hopeful that their applications for interchangeable status for insulin glargine (Semglee) and adalimumab (Cyltezo) biosimilars, respectively, will be approved this year. Interchangeable status is distinctly a United States appellation. There are no interchangeable designations for biosimilars in the European Union, where the European Commission approves biosimilars and member states and countries make their own decisions about pharmacy counter substitution.
We at Samsung Bioepis believe a class of interchangeability products may cause misunderstanding and misinterpretation of the scientific rigor that goes into the biosimilar approvals process.
Biosimilars are approved by the FDA as equally safe and efficacious with no clinically meaningful differences to the originator products they reference. Years of positive clinical experience with biosimilars have justified these approvals. However, the pending arrival of a class of interchangeables—biosimilars that pharmacists can dispense in place of reference products without physician authorization—threatens to give the impression that these agents are somehow superior to standard biosimilars, Kim said.
“We at Samsung Bioepis believe a class of interchangeability products may cause misunderstanding and misinterpretation of the scientific rigor that goes into the biosimilar approvals process,” he said.
Biosimilar candidates undergo multiple levels of testing to gain regulatory approval, ranging from analytical testing for structure and function to human trials to compare safety and efficacy of the product candidates with originator agents. Interchangeables must undergo additional clinical trials to verify that multiple switches from originator to biosimilar and back again will result in no safety or efficacy variations.
Biosimilars Have Proved Themselves
At Samsung Bioepis, the consensus is that the evidence requirements for biosimilars alone are already sufficient to qualify these products for interchangeable status.
“Biosimilars have been around now for more than a decade around the world, and there has been no evidence of altered pharmacokinetics data, or heightened immunogenicity response, or increased safety risk, or improved or diminished efficacy in patients who switch back and forth from reference drugs to biosimilars or between biosimilar drugs,” Kim said.
He noted that the company is not seeking interchangeable status for its biosimilars at this time.
“We hold the position that the interchangeability designation is not necessary to drive the adoption of biosimilars in order to lessen the health care burden in the United States," he said.
Although Samsung Bioepis is looking askance at the interchangeability designation, Viatris expects it to give the company’s insulin glargine and insulin aspart products a marketing edge. Viatris anticipates FDA approval of an insulin glargine (Semglee) as an interchangeable by July 2021. The product was approved last year, but not as a biosimilar, as the product application did not go through the biosimilar regulatory approval pathway at the FDA.
“We see this as an opportunity to sort of relaunch this product,” Rajiv Malik, president of Viatris, said in an investor call accompanying the company’s first quarter 2021 earnings report. “Once we have interchangeability, it’s our opportunity to basically relook at the challenges we have faced so far in picking up market share.”
BioRationality: MHRA's Procedure Enables Automatic Registration of Biosimilars Approved Elsewhere
March 18th 2024Sarfaraz K. Niazi, PhD, explains how the new international regognition procedure under the Medicines and Healthcare products Regulatory Agency (MHRA) could expand biosimilar access within the United kingdom, in his latest column.
Exploring the Biosimilar Horizon: Julie Reed's Predictions for 2024
February 18th 2024On this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum, returns to discuss her predictions for the biosimilar industry for 2024 and beyond as well as the impact that the Forum's 4 new members will have on the organization's mission.
Coherus Biosciences Cites Biosimilars as Main Drivers of 2023 Revenue Growth
March 14th 2024In its earnings report for the fourth quarter and full year of 2023, Coherus Biosciences detailed its rising revenue growth, which it partly attributed to increased sales for its pegfilgrastim and ranibizumab biosimilars.
A New Chapter: How 2023 Will Shape the US Biosimilar Space for 2024 and Beyond
December 31st 2023On this episode of Not So Different, Cencora's Brian Biehn and Corey Ford take a look back at major policy and regulatory advancements in 2023 and how these changes will alter the space going forward.
Filgrastim Biosimilars in Europe: 15 Years of Real-World Evidence for Zarxio
March 13th 2024A review looking back at the last 15 years of experience with the first filgrastim biosimilar (Zarxio) provides a detailed overview on how filgrastim biosimilars came to be and the evidence behind why oncologists have come to accept them as standard practice.
HLX02, Pertuzumab, Chemotherapy Combination Effective, Safe in Advanced HER2-Positive Breast Cancer
March 12th 2024A study found combining trastuzumab biosimilar HLX02, pertuzumab, and chemotherapy was effective and safe for patients with HER2-positive metastatic breast cancer who progressed after prior trastuzumab therapy.