FDA approves ‘Siltezo’ interchangeable biosimilar… Second time after ‘Semgli’
Occupying an advantageous position to enter the US Humira market compared to competing biosimilars
Prior to Amgen, Samsung Bioepis, Sandos, Kyowa Kirin, Pfizer, etc.
[팜뉴스=이권구 기자] The US FDA announced on October 18 that it had approved Cyltezo on October 15 as the first interchangeable (replaceable) biosimilar of Humira.
With this, Siltezo became the second ‘interchangeable biosimilar’. On July 28, the FDA approved the diabetes treatment Semglee as the first alternative biosimilar.
If it is designated as an interchangeable biosimilar, it is reflected in the labeling and a pharmacy-level substitution is possible with the original drug without the intervention of the prescribing doctor.
The U.S. Food and Drug Administration (FDA) states that if a biosimilar developer can prove that a biosimilar or original drug can produce the same clinical results no matter what patient it is prescribed to, the biosimilar can be ‘interchangeable’. It can be specified as a Miller.
Cyltezo, developed by Boehringer Ingelheim in Germany, is a biosimilar product of AbbVie Humira in the US, an original drug. additional permits were obtained.
Humira is a treatment used for autoimmune diseases such as rheumatoid arthritis and is the world’s No. EvaluatePharma, a pharmaceutical market research firm, predicted that Humira, which recorded $20 billion in sales in 2020, will plunge to $14.5 billion in 2026 due to the expiration of its patent in 2023.
In relation to this approval, the Korea Biotechnology Association predicted through a report that Siltezo is scheduled to be released in July 2023 and has been designated as an interchangeable biosimilar and has taken an advantageous position in entering the US Humira market compared to other competing biosimilars. .
According to the report, Amgen’s Amjevita, which had previously received FDA approval as a biosimilar, will be released in January 2023, Samsung Bioepis’ Hadlima in June 2023, and Viatria and Fujifilm Kyowa Kirin’s Hulio in June 2023.
July 2023, Sandoz’s Hyrimoz in September 2023, and Pfizer’s Abrilada in November 2023.
Original pharmaceutical companies use active patent defense strategy to contain biosimilar entry
In addition, Iceland’s Alvotech is aiming to obtain an interchangeable biosimilar license for Humira biosimilar (AVT02), which is in phase 3 clinical trial. It is rapidly advancing into the US market.
The results of the patent litigation between Alvotech and AbbVie are expected to come out as early as October this year.
On the other hand, original pharmaceutical companies are actively taking patent defense strategies to check the entry of biosimilars.
In fact, Humira, the number one in global sales, has more than 100 patents. Compared to chemical drugs, which usually have about 10 patents, the report diagnosed that biopharmaceuticals are a complex manufacturing process and patent applications are possible in the process.
Although the main patent for Humira ended in 2014, it continues to apply for patents and is defending the patent until 2034. In 2015 alone, 32 patents were granted, and in 2016, an additional 21 patents were obtained.
AbbVie claimed that 61 patents were infringed in a patent litigation with Amgen, which received approval for the Humira biosimilar, and 74 patents were infringed by Boehringer Ingelheim.
According to the report, “AbbVie Chairman and CEO Richard Gonzalez announced his patent defense strategy for Humira in 2015, reducing the average time it takes for a patent litigation in courts (3.35 years + Appeals court approx. 1 year) to take on average 4 to 5 years. Therefore, Humira sales will continue to increase.”
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