- The European Medicines Agency late last week recommended eight drugs for approval, including Amgen's biosimilar version of AbbVie's blockbuster anti-inflammatory Humira (adalimumab).
- Amgen originally submitted its copycat treatment for approval in the European Union in December 2015. While the company got the green light to sell the drug in the U.S. back in September, its launch has been held up by patent litigation.
- The agency's Committee for Medicinal Products for Human Use (CHMP) also revealed Novartis's Sandoz unit had withdrawn its application for approval of Zioxtenzo, a biosimilar to Amgen's Neulasta (pegfilgrastim).
The conclusions from CHMP's January meeting largely aid Amgen. The company gained a positive opinion for Amgevita (marketed as Amjevita in the U.S.), which could now become the first biosimilar to Humira authorized for use by the European Commission. Additionally, the setback from Novartis' biosimilar of Neulasta will delay any regulatory action on the copycat candidate for the time being.
While not Amgen's top earner, Neulasta still brought in sales of $1.2 billion during the third quarter.
Novartis' generics and biosimilars unit Sandoz withdrew the Zioxtenzo application on Jan. 18. At the time, the CHMP had concerns about the manufacturing practices for the drug and how closely it actually mirrored Neulasta.
"Sandoz will not be able to provide the additional information required by the ChMP within the regulatory timeframe for this procedure," the company said in a Jan. 18 letter to the committee. "Sandoz will continue to collaborate with EMA to make this product available to the patients in the EEA and intends to resubmit the application as soon as the outstanding information is available."
Novartis said in its fourth quarter earnings report it plans to resubmit Zioxtenzo for European approval later this year. It also plans to resubmit the drug in the U.S. in 2018, after addressing concerns the FDA raised in a complete response letter issued last year.
CHMP also advocated for the approval of Pfizer's Xeljanz (tofacitinib), Therakind's Jylamvo (methotrexate), Amgen's Solymbic (adalimumab), GlaxoSmithKline's Rolufta (umeclidinium), Eli Lilly's Tadalafil Lilly (tadalafil), JensorR+'s Yargesa (miglustat), and Hospira U.K.'s Daptomycin Hospira (daptomycin).
In addition to the eight medications receiving positive opinions, CHMP recommended label expansions for Celgene's Revlimid (lenalinomide) and Eli Lilly's Synjardy (empagliflozin/metformin HCl).