Celltrion/Teva Rituxan biosimilar edges closer to US approval

It looks increasingly likely that Roche’s cancer blockbuster Rituxan (rituximab) will face competition from a cheaper biosimilar in the coming months after backing from an FDA expert committee.

Advisers to the FDA, sitting on its Oncologic Drugs Advisory Committee voted 16-0 in favour of approval of CT-P10, Celltrion’s biosimilar of Rituxan, following a glowing review by the regulator’s staff reviewers.

South Korea's Celltrion and marketing partner Teva are seeking approval in the drug’s oncology indications.

The FDA is not bound to follow the advice of its committees when making regulatory decisions, but a positive vote vastly increases the chance of approval.

Shares in Roche ticked down following the decision, suggesting that investors think Rituxan will finally face competition after 21 years on the market.

Rituxan’s US patent expired this year, meaning that Teva and Celltrion will likely be able to launch their biosimilar shortly after any decision to approve.

In Europe, where rituximab already faces biosimilar competition, sales were down 47%, according to Roche’s sales figures for the first half of this year.

Annual sales of Rituxan in the US exceeded $4 billion according to the company’s sales figures for last year.

Celltrion and Teva entered into an exclusive partnership in October 2016 to market CT-P10 in the US and Canada.

Indications targeted by the companies are relapsed or refractory, low-grade or follicular, CD20-positive, B-cell Non-Hodgkin’s Lymphoma (NHL) as a single agent.

Also targeted is the use in previously untreated follicular, CD20-positive, B-cell NHL in combination with first-line chemotherapy and as a maintenance therapy who respond.

The companies also seek approval in non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line chemotherapy.

Woosung Kee, CEO of Celltrion, said: “We welcome the Oncologic Drugs Advisory Committee’s recommendation. If approved by the FDA, CT-P10, a proposed biosimilar to Rituxan, will be the first rituximab biosimilar to be approved in the United States for the three proposed indications."