In first quarter 2023 financials, the company reported a drop in net revenue of close 10%, as the impact of Humira biosimilar entry onto the market begins to bite.
Amgen is launching Amjevita, or adalimumab-atto, a biosimilar to AbbVie’s Humira, in the US; it is the first such biosimilar to the blockbuster drug in that market.
A study has demonstrated the effectiveness and safety of adalimumab biosimilars Hulio and Hyrimoz in the therapy of patients with inflammatory bowel disease (IBD).
Teva Pharmaceutical Industries has given a bullish assessment of its chances of claiming a big slice of the Humira biosimilar market, arguing it has “the best product profile of all companies coming to the market in 2023.”
The US FDA has accepted a supplemental biologics license application (sBLA) from Sandoz for a high concentration formulation of 100 mg/mL (HCF) of its biosimilar, Hyrimoz.
The House Committee on Oversight and Reform plans to subpoena AbbVie over pricing of Humira and Imbruvica, alleging the company repeatedly failed to comply with requests.
AbbVie frames forecast-beating ex-US sales of Humira as a consequence of prices stabilising earlier than expected after the arrival of biosimilar competitors.
Though the utilization of biosimilars in Europe is high, a report on the practices of eight countries suggests that more can be done to foster competition and remove barriers to entry.
US FDA gives approval to Samsung Bioepis’ Humira biosimilar and Pfizer’s Rituxan biosimilar, as the number of such medicines gaining entry onto the US market steadily increases.
With US spending on biologics reaching $125.5bn in 2018, a new report looks at the level of savings that could potentially be made and contrasts the US with the European market.
Boehringer Ingelheim settles litigation with AbbVie over the possible introduction of its Humira biosimilar and agrees a license to market its competitor in 2023.
AbbVie receives approval from the US FDA for its newest psoriasis drug, Skyrizi, which looks set to recoup some of Humira’s revenue when it loses patent protection.
A judge has ruled in favour of AbbVie, finding that Boehringer should disclose its US launch plans for its Humira biosimilar if it wants to prove patent protection inhibited its commercial release.
Active competition law enforcement is encouraging the pharmaceutical industry to provide more affordable medicines and promotes innovation, suggests EC report.
Biosimilar approvals in the US have increased by 600% and with biologic patent expiration dates approaching, biosimilar applications are on the rise as well.
2018 saw an increase in the number of biosimilar approvals, and the expiry of patents on major products that allowed the entry of biosimilars across Europe.
At least 80% of patients currently taking AbbVie’s blockbuster drug could be switched to “the best value biological medicine” within 12 months, according to the UK National Health Service.
The California Department of Insurance has sued AbbVie for allegedly providing monetary gifts to health-care providers for prescribing its biologic, Humira.
