The UK’s healthcare cost watchdog has updated its methods for reviewing biosimilar applications in anticipation of the products’ increasing availability in the country.

Biosimilar applications for national coverage generally will be reviewed under a multiple technology appraisal process along with the reference product, according to a Jan. 6 position statement from the UK’s National Institute for Health and Care Excellence.

Positive appraisals of biosimilars will use the name of the active drug substance, including the reference product and brand name, to inform clinical decisions, NICE said.

In other circumstances, where the agency does not make a recommendation, NICE said it will issue an “evidence summary new medicine.” Evidence summaries of the biosimilar will include the therapy’s brand name because substitutability and interchangeability cannot be assumed, the agency added. Such summaries will leave the decision to use the biosimilar or originator biologic up to the physician.

Biosimilars already are covered to some extent by the National Health Service, NICE said, and the agency has included biosimilars in its technology appraisal on the human growth hormone somatropin. Their availability and use is expected to become more widespread over the next few years, NICE added.

Several top-selling biological medicines have lost or will soon lose patent protection, including monoclonal antibodies for use in patients with cancer, rheumatoid arthritis and other inflammatory diseases and insulins for diabetes, NICE said.

Read the updated position statement at www.fdanews.com/01-07-15-NICEbiosimilar.pdf. — Neal Learner