Momenta and Mylan's Proposed Orencia Biosimilar Fails to Meet Phase 1 Primary PK Endpoints

Momenta Pharmaceuticals and Mylan N.V.

announced

today that M834, the companies’ proposed biosimilar of Bristol-Myers Squibb’s Orencia (abatacept), did not meet its primary pharmacokinetic (PK) endpoints in a phase 1 study comparing the PK, safety, and immunogenicity of M834 compared with US- and EU-sourced Orencia.

The phase 1

study

was a randomized, double-blind, 3-arm, parallel-group, single-dose, subcutaneous administration clinical study in 243 healthy volunteers ages 18 to 55.

Primary outcome measures included:

• Maximum serum concentration (Cmax) pre-dose and post-dose through day 85
• Area under the serum concentration curve (AUC) vs time curve from zero to last quantifiable concentration
• AUC from time zero extrapolated to infinity

Secondary outcome measures included:

• The incidence of anti-drug antibodies
• Count and percentages of adverse events by treatment group

Orencia is approved in the United States, European Union, and Japan for the treatment of rheumatoid arthritis (RA), including the treatment of those patients who have not been helped enough by other medicines for RA. Orencia may be used in adults alone or with RA treatments other than tumor necrosis factor (TNF) antagonists. In the United States and European Union, Orencia is also approved for the treatment of psoriatic arthritis and juvenile idiopathic arthritis.

In 2016, worldwide

sales

of Orencia totaled $2.4 billion. There are no currently approved abatacept biosimilars; the patents on the originator product expire in the US in October 2019 and in Europe in December 2017.

According to an August 2017 study published in Clinical Therapeutics, the overall cost per patient per year of infusion therapy for Orencia was $46,532.

The Generics and Biosimilars Initiative

reports

that the only other abatacept biosimilar being developed is that of BioXpress Therapeutics.

Craig Wheeler, president and CEO of Momenta Pharmaceuticals, said that the phase 1 results were unexpected and disappointing. “We are in the process of gathering the full data set and will work with Mylan to fully analyze these data to better understand the study results and evaluate next steps for this program,” he said. “We remain committed to executing on our biosimilar portfolio.”

Mylan and Momenta are collaborating on biosimilars, and are jointly responsible for product development, with Mylan leading worldwide commercialization efforts.

Momenta’s biosimilar pipeline includes a number of programs, but only 2 have been publicly disclosed—M834 and a biosimilar of adalimumab (AbbVie’s Humira), M923.