CHMP Favors At-home Injection Form of Remsima for Europe

The Committee for Medicinal Products for Human Use (CHMP), a branch of the European Medicines Agency (EMA), is recommending the use of a subcutaneous (under the skin) injection formulation of Remsima (infliximab) by people with ankylosing spondylitis and four other disorders.

Celltrion Healthcare designed this new version of its biosimilar, called Remsima SC, to be self-administered in typically less than two minutes. Remsima, known as Inflectra in the U.S., must be administered by intravenous (IV) infusion, a slow process that delivers a medication directly into the bloodstream.

Specifically, CHMP recommended a 120 mg dose of Remsima SC in adults regardless of body weight. The therapy has three administration options: via a pre-filled pen, pre-filled syringe, or a pre-filled syringe with needle safeguard.

The EMA will now decide whether to support Remsima SC for these five indications; the European Commission has the final decision.

“Since its first launch, Remsima has been used for more than 5 years in over 90 countries,” said Hyoung-Ki Kim, vice chairman at Celltrion, in a press release. “This positive CHMP opinion is very encouraging and brings us closer to improving outcomes for more patients who are eligible to receive the subcutaneous formulation.”

Biosimilars are to biologics what generics are to conventional medications. They have similar safety, efficacy, dosing, and route of administration to a reference biologic, and are manufactured by a different company after the original product’s patent expires. Usually, biosimilars are sold at considerably lower prices than reference therapies.

Remsima is an anti-inflammatory therapy that consists of the monoclonal antibody infliximab. It is a biosimilar of Remicade (infliximab), developed by Janssen. Both Remsima and Remicade work by blocking the activity of a pro-inflammatory protein called TNF-alpha.

Remsima SC was approved by the EMA as a treatment for rheumatoid arthritis in November 2019.

CHMP is now recommending, in addition to ankylosing spondylitis, that Remsima SC treat Crohn’s disease, ulcerative colitis — two forms of inflammatory bowel disease — psoriatic arthritis, and psoriasis. Adults with any of these disorders can now be treated with the IV approach.

“If approved by the EMA, Remsima will be the first infliximab to have both intravenous and subcutaneous formulations to treat patients with ankylosing spondylitis, Crohn’s disease, ulcerative colitis, psoriatic arthritis and psoriasis,” Kim said.

The opinion supporting Remsima SC comes after a Phase 1 clinical trial (NCT02883452) that compared Remsima SC to its IV form found that both versions had similar safety and efficacy in people with Crohn’s disease and ulcerative colitis.

Remsima was given a two-hour IV infusion every eight weeks, Remsima SC as a single injection every two weeks.

The study’s first part showed that Remsima SC had similar clinical response and led to higher disease remission than the IV dosing. In a second and maintenance phase, 66 patients were randomly assigned to Remsima SC and 65 to Remsima IV injections. Remsima was given every two weeks at 120 mg to patients weighing less than 80 kg (nearly 176 lbs) and at 240 mg to heavier participants. Patients on the IV formulation were given 5 mg/kg of Remsima every eight weeks. At week 30, all were given the SC formulation; 105 patients completed the final visit at week 54.

Researchers found both treatment forms were safe and durably reduced disease activity. Blood levels of Remsima at study’s end were similar between those who on continuous Remsima SC therapy and those who switched from IV dosing.

“Today’s positive CHMP opinion marks an important step forward in furthering our ability as clinicians to meet the needs of people with autoimmune diseases. Remsima SC could offer patients an alternative administration method that provides adequate exposure during maintenance treatment with infliximab … reducing the time patients need to be in medical settings with infusion administrations,” said Walter Reinisch, director of the Clinical IBD Study Group at the Medical University of Vienna.

“Given the current COVID-19 pandemic, this is timely and welcome news, particularly for immunocompromised patients who must take extra precaution and only visit hospitals when absolutely necessary,” he added.