Humira

In December of 1991, the journey of Humira began with the Cambridge Antibody Technology Group in the UK. Through genetic engineering, the group created an artificial immune system that could replicate human antibodies, leading to the development of technology exploring therapeutic uses of these antibodies.

In 1993, CAT entered a joint collaboration with BASF Pharma to utilize phage display technology for producing fully human antibodies to TNF-α, a protein linked to autoimmune diseases like rheumatoid arthritis.

In January of 1994, Knoll AG of BASF Pharma collaborated on phage technology related to Humira's development. This collaboration played a crucial role in advancing the research and technology behind Humira.

Two years later, in 1995, Tristan Vaughan, a scientist at CAT, isolated a potential drug candidate named D2E7 using phage display technology. D2E7, now known as adalimumab, binds effectively to TNF-α, blocking inflammation in humans.

BASF Pharma announced positive results of the investigational human monoclonal antibody D2E7 in treating rheumatoid arthritis during a phase I clinical trial with 140 patients.

Originally known as D2E7, Humira was introduced after Abbott Laboratories acquired Knoll Pharmaceuticals in 2000. Analysts had high expectations for the drug, predicting significant annual revenue potential.

Only two years after its discovery, clinical trials started to test adalimumab, the precursor of HUMIRA®, as a potential treatment for rheumatoid arthritis.

On December 31, 2002, the FDA approved Humira (adalimumab) for the treatment of Rheumatoid Arthritis.

Humira, with the active substance adalimumab, received marketing authorization on September 8, 2003.

On October 4, 2005, Humira received FDA approval for the treatment of Psoriatic Arthritis.

On July 31, 2006, Humira received FDA approval for the treatment of Ankylosing Spondylitis.

On February 27, 2007, the FDA approved Humira (Adalimumab) for the treatment of Crohn's Disease.

On January 22, 2008, the FDA approved Abbott's Humira (adalimumab) for the treatment of moderate to severe chronic plaque psoriasis.

On February 22, 2008, Abbott received FDA approval for Humira (Adalimumab).

All authorised presentations of Humira were first published on June 23, 2009, and last updated on July 27, 2021.

The product information for Humira was first published on November 12, 2009, and last updated on October 11, 2022.

The designation for biosimilars was created by legislation authorizing the FDA's biosimilar regulations.

On September 28, 2012, the FDA approved Humira to treat ulcerative colitis.

On September 25, 2014, the FDA approved Humira (adalimumab) for the treatment of pediatric patients with Crohn's disease.

On September 11, 2015, the FDA approved Humira (adalimumab) for the treatment of moderate to severe hidradenitis suppurativa.

On June 30, 2016, AbbVie's Humira (adalimumab) received FDA approval to treat adults with non-infectious intermediate, posterior, and panuveitis.

On March 30, 2017, the FDA approved the addition of moderate to severe fingernail psoriasis data to AbbVie's Humira (adalimumab) prescribing information.

On September 5, 2018, AbbVie's blockbuster drug Humira reached a sales peak of $18.9 billion. This significant milestone highlighted the drug's immense commercial success in the global market.

In February 2020, the biosimilar Amsparity was approved for use in the European Union.

In June 2020, the biosimilar Idacio was approved for use in Australia.

In July 2020, adalimumab-fkjp (Hulio) was approved for use in the United States.

In August 2020, the biosimilar Cadalimab was launched in India by Cadila Pharmaceuticals.

Idacio was approved for medical use in Canada in October 2020.

In November 2020, Amgevita, Hulio, and Hyrimoz were approved for medical use in Canada.

On February 24, 2021, the FDA approved Humira (adalimumab) for the treatment of pediatric patients with moderately to severely active ulcerative colitis.

An assessment report for Humira was adopted on July 13, 2021.

An assessment report for Humira was adopted on July 18, 2021.

Biosimilar copies of Humira are set to enter the U.S. market, posing a challenge to AbbVie's monopoly on the drug. This development will test the market potential of knockoff biologic drugs.

An assessment report for Humira was adopted on August 2, 2022.

A procedure affecting the product information of Humira was initiated on October 10, 2022.

An assessment report for Humira was adopted on October 14, 2022.

The patent exclusivity for Humira in the US extends until 21 January 2023, delaying the entry of biosimilars by Amgen and Samsung Bioepis into the market.

An update on the status of biosimilar copies of Humira, indicating ongoing developments in the market. This update provides insights into the changing landscape of biologic drug competition.

AbbVie, the manufacturer of the blockbuster drug Humira, utilized the U.S. patent system to delay competition and maintain a monopoly on the drug, resulting in rising prices. The monopoly, which generated $114 billion in revenue for AbbVie, is expected to end as competitors enter the market.

In February 2024, adalimumab-ryvk (Simlandi) was approved for medical use in the United States.

AbbVie executives are optimistic about the sales forecast of Skyrizi and Rinvoq, expecting a combined revenue of $17.5 billion by 2025. This projection is a significant increase from the $4.6 billion earned in 2020, surpassing Humira's peak sales of $20 billion.