Amgen became the first biosimilar maker to receive recommended European approval for not one but two adalimumab biosimilars, after the EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for its products Amgevita and Solymbic last Friday.
The products are identical molecules, and both are set to be available as a solution for injection to treat: rheumatoid arthritis, juvenile idiopathic arthritis (JIA), axial spondyloarthritis, psoriatic arthritis, psoriasis, paediatric plaque psoriasis, hidradenitis suppurativa (HS), Crohn’s disease, ulcerative colitis and uveitis. Amgevita has also been approved for the indication paediatric JIA, though Solymbic has not.
As such, it appears Amgen is intent on following a two-brand strategy in Europe, much like Korean drugmaker Celltrion has done with its Remicade (infliximab) biosimilar, with Inflectra and Remsima being available through its partners across the continent’s different territories.
In 2015, Celltrion told us: “A two-brand strategy for the same product is not uncommon in the industry. Due to marketing matters, including cultural differences and different distributors in local markets, pharmaceutical companies use multiple brand names catering to local needs.”
Amgen has already seen regulatory success with its adalimumab biosimilar which was approved in the US last September under the brand name Amjevita. The firm has said it is unlikely to launch the product this year, however, due to ongoing legal disputes with AbbVie.
A number of biosimilar makers are looking to grab a slice of the Humira market, which last year clocked in sales of over $16bn for AbbVie. Just last week Boehringer-Ingelheim announced it was the latest entrant, with its adalimumab drug – BI 695501 – being accepted for review by both the EMA and US FDA.
AbbVie ‘comfortable’ with erosion
Speaking Friday to discuss its end of year results, AbbVie CEO Richard Gonzalez told investors for the vast majority of countries biosimilars will be able to enter the marketplace during the fourth quarter of 2018, when Humira’s exclusivity expires.
He also used the examples of Janssen’s Remicade biosimilar and Amgen’s Enbrel as to suggest how AbbVie’s market share is likely to erode.
The former, which he said are available in about 66 countries “have about just under 5% of the overall market and they have about just under 25% of the molecule share.”
Enbrel biosimilars are in about 34 countries, and “the latest data says that they had just over 3% share of the overall category and about 14% or 15% share of the molecule,” he continued.
“We continue to monitor this and we feel comfortable with what the erosion curve continues to look like.”
UPDATE - Solymbic doesn't have labelling approval to treat paediatric JIA, but Amgevita does. The original article did not make this clear