After Announcing Global Biosimilar Initiative, Sandoz Sees EU Biosimilar Application Acceptance

Not long after the company announced its new global initiative to promote access and increase adoption of biosimilars, Sandoz’ biologics license application for its high-concentration adalimumab biosimilar was accepted by the European Union’s regulatory agency for review.

Act4Biosimilars and Sandoz

In late May Sandoz announced its sponsorship of a new global initiative, Act4Biosimilars, which aims to promote access and increase adoption of biosimilars in over 30 countries by 2030. The initiative is supported by a multidisciplinary Steering Committee including patient advocacy leaders, health care providers, biosimilar industry leaders.

“Healthcare systems are facing more pressure than ever before, which can be attributed to the costs associated with a growing, aging population, more people being diagnosed with chronic diseases and, most recently, the pandemic…. Biosimilars are part of the solution to support a more sustainable healthcare system for all,” said Richard Saynor, CEO of Sandoz, in a statement.

The main goal of the initiative is to increase approvability, accessibility, acceptability, and affordability of biosimilars and to increase global adoption of biosimilars by at least 30% in 30 plus countries by 2030.

Act4Biosimilars has 12 goals for achieving the main mission, including ensuring equitable pricing, involving patient in decision-making conversation surrounding treatment, and streamlining the biosimilar development process.

“As a result of their affordability, biosimilars have opened up a new realm of possibility for patients by enabling biological medicines to become more widely available to those in need of these advanced, life-changing treatments…. However, until we address existing biosimilar access inequities, far too many patients will continue to miss out on treatment with the best possible medicines,” said Zorana Maravic, CEO of Digestive Cancers Europe, in Sandoz’ announcement statement.

EMA Accepts BLA for Sandoz’ High-Concentration Adalimumab Candidate

Just a few weeks after the announcement of Act4Biosimilars, Sandoz said that its biologics license application (BLA) was accepted for review by the European Medicines Agency (EMA). The BLA references the high-concentration, citrate-free (100 mg/ml) of Sandoz’ adalimumab biosimilar to Humira, Hyrimoz.

The company is seeking approval for all indications for the reference product, including rheumatoid arthritis, Crohn disease, ulcerative colitis, plaque psoriasis, and uveitis. If approved, the high-concentration, citrate-free formulation (HCF) of Hyrimoz would offer patients the ability to go longer periods in between adalimumab doses and a smaller needle compared to patients receiving lower-concentration adalimumab.

Hyrimoz HCF can be administered through the same auto injector as the original 50 mg/mL of Hyrimoz, which Sandoz said will aim to secure “an enhanced yet familiar patient experience.”

The submission of the BLA was supported by positive pharmacokinetics (PK) data from a phase 1 study comparing the newer and older version of Hyrimoz, in which the study met all its primary objections and demonstrated comparable PK, safety, and immunogenicity profiles between Hyrimoz HCF and the original formulation. The original Hyrimoz was granted marketing authorization by the European Commission in July 2018.

“At Sandoz, we are constantly looking for ways to meet the changing needs of patients and health care providers…. By committing to bring biosimilar formulations such as Hyrimoz citrate-free HCF to patients, we are serving a critical need in expanding access to important medicines and fueling pharmaceutical innovation,” said Florian Bieber, global head of biopharmaceuticals development at Sandoz, in a statement.

In addition to the high- and low-concentrations of Hyrimoz, Sandoz also has 8 marketed biosimilars; including Erelzi (etanercept biosimilar), Zessly (infliximab biosimilar), and Rixathon (rituximab biosimilar; and over 15 more in development.