Humira biosimilar from Samsung Bioepis and MSD wins marketing authorisation in the US

pharmafile | July 24, 2019 | News story | Research and Development, Sales and Marketing AbbVie, Humira, MSD, Samsung Bioepis, biosimilars, pharma 

It’s another victory for MSD as the US drugmaker announced that its biosimilar version of AbbVie’s Humira – the world’s best-selling medicine – has received marketing authorisation from the FDA.

The approval for the drug, known as Hadlima and developed by Samsung Bioepis, covers the treatment of rheumatoid arthritis (RA), juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis and plaque psoriasis, just like its reference product.

The approval marks the fourth in the US for a Samsung Bioepis biosimilar. Commercialisation of the drug will be handled by MSD. The decision came with a warning over the risk of serious infection from diseases such as tuberculosis and bacterial sepsis on use of the drug, as represented in a black box warning on the packaging.

“With the approval of Hadlima, we are proud to have three anti-TNF biosimilars approved in the US. We believe the US healthcare system can benefit from biosimilars, as they could play an important role in broadening access to treatment options for patients with autoimmune conditions,” commented Hee Kyung Kim, Senior Vice President and Head of Regulatory Affairs at Samsung Bioepis. “We remain committed to advancing our strong pipeline of biosimilar candidates, so that more patients and healthcare systems can benefit from biosimilars.”

Thanks to a prior license agreement with AbbVie, the drug is expected to launch in the US after 30 June 2023.

Matt Fellows

Related Content


Samsung Bioepis & Biogen receive positive CHMP opinion for ranibizumab biosimilar

Samsung Bioepis and Biogen have announced that the EMA’s Committee for Medicinal Products for Human …


MSD announce new data from advanced renal cell carcinoma trial

Merk (MSD) has announced positive data from its Phase III Clear/Keynote-581 trial on Keytruda (pembrolizumab) …

Biosimilars and Brexit: What’s in store for UK’s biosimilar market?

It’s been 15 years since the first biosimilar entered the market, and the impact of …

Latest content