With FDA’s Approval of the Second Biosimilar, Humira to Fight for the Glory of King!

There comes the second FDA-approved biosimilar of AbbVie’s branded drug Humira (adalimumab), as the tumor necrosis factor (TNF) blocker Cyltezo of Boehringer Ingelheim was approved for marketing by FDA on August 25.

Boehringer’s Humira biosimilar wins US green light in August.

As the absolute pillar product of AbbVie, Humira realized USD 16.078 billion sales revenue in 2016, accounting for 61% of the performance of AbbVie in the year. Humira is the current king in the annual sales rankings of global pharmaceutical products: Humira stayed on the position of Top 1 among world’s best-selling pharmaceutical products in the past 5 years, and it has created the good performance of annual sales exceeding USD 10 billion for 4 consecutive years since 2013.

Lessons drawn from mistakes of previous biosimilar of Humira

FDA approved the marketing application of Amjevita, a Humira biosimilar developed by Amgen, in September 2016. Amjevita was approved by the EU in March this year to become the first Humira biosimilar approved for marketing in the European market. The active ingredient of this drug is an anti-TNF-α monoclonal antibody that has the same amino acid sequence as Humira.

However, Amjevita has not been marketed so far, with Amgen’s failure in the patent challenge to AbbVie’s Humira and AbbVie’s patent infringement litigation against Amjevita monoclonal antibody, in other words, the marketing approval received by Amjevita has not brought any expected sale proceeds to Amgen. How did the "size of shadow" in the heart of Amgen, the developer of the first biosimilar of the drug king Humira, change in the nearly one year after FDA’s approval?

Biosimilars VS brand original drug

Some similarities and differences between the biosimilars Amjevita and Cyltezo, and the brand original drug Humira are mainly as follows:

Same indications approved by FDA: the indications approved by FDA for the biosimilars Amjevita and Cyltezo are same as Humira, including 7 indications such as rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis.

Different product doses: Amjevita’s dose includes 20mg/0.4mL and 40mg/0.8mL, currently Cyltezo only has the dose of 40mg/0.8mL, while the original drug Humira has multiple doses including 10mg/0.1mL, 10mg/0.2mL, 20mg/0.2mL, 20mg/0.4mL, 40mg/0.4mL, 40mg/0.8mL and 80mg/0.8mL, etc.

Different scopes of application to the patient populations with juvenile idiopathic arthritis: currently Amjevita is applicable to such patients with weight of above 15kg, Cyltezo is only applicable to such patients with weight of above 30kg, while Humira is applicable to such patients with no weight restriction.

Humira’s defending war for the glory of king

Humira is now facing challenges of biosimilars: in addition to the Amjevita and Cyltezo approved for marketing by FDA, pharmaceutical giants including Pfizer, MSD, Samsung Bioepis, Novartis and Baxter, etc. are also actively conducting layout of biosimilars of Humira.

Nonetheless, the plight of the first biosimilar Amjevita is warning the latecomers: Humira still has the strength of a king, therefore, be cautious if to challenge it! Where the road ahead of Cyltezo, the second biosimilar approved by FDA for marketing, will lead is still a question.

It is particularly noteworthy that the outside world is still very optimistic about the future sales expectations of Humira, which, in some extent, is a comprehensive reflection based on the multiple feel-good factors of Humira:

Firstly, the stable clinical efficacy performance of Humira is the basis for the sales performance of this drug;

Secondly, AbbVie continues to expand new indications of Humira and extend its clinical application potential;

Thirdly, Humira has multiple dosage forms available for use, therefore, patients’ medication adherence is very high;

Fourthly, and very importantly, AbbVie has constructed a strong patent protection system for Humira. Take the U.S. market for instance, Humira possesses up to 70 U.S. patents, with the expiration time mostly between 2022 and 2034. The multiple patent protection system largely extends the lifecycle of Humira.

According to the research report issued by EvaluatePharma earlier, the world’s best-selling drug will still be Humira in 2022, and Humira is expected to create the good performance of annual sales exceeding USD 10 billion in another 6 years, and continues its glory of king.

By Xiaoyaowan