Boehringer Ingeheim's biosimilar to AbbVie's mega blockbuster Humira has been accepted for review on both sides of the Atlantic, after having shown comparability in late-stage trials.
Humira (adalimumab), an anti-TNF monoclonal antibody, pulls in annual sales of nearly $15 billion across its range of indications for inflammatory diseases.
It is currently approved in the US, EU and other markets for multiple indications including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn's disease, paediatric Crohn's disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa and uveitis.
"We believe that if approved, BI 695501 can provide a valuable treatment option for the people affected by inflammatory diseases in the US and Europe," said Ivan Blanarik, senior vice president and Head of Therapeutic Area Biosimilars, at the firm.
"The acceptance of our first biosimilar regulatory filings by the FDA and EMA is an important milestone towards offering a high-quality treatment choice to patients and physicians while contributing to the sustainability of healthcare systems."
The German drugmaker currently has two biosimilar monoclonal antibodies in late stage development: BI 695501a and BI 695502, a biosimilar to Rcohe's Avastin (bevacizumab).
US regulators issued a green light for the first biosimilar of AbbVie's biologic - Amgen's Amjevita - in September last year.