Eye on Pharma: Steps Forward for Etanercept Biosimilars Worldwide

Three drug developers have made recent strides forward with their biosimilars or proposed biosimilar referencing Enbrel (etanercept), with new product approvals, manufacturing developments, and growing sales.

LG Chem Wins Japanese Approval for LBEC0101

Yonhap news agency reports that the Republic-of-Korea—based LG Chem has gained authorization from the Japanese Ministry of Health, Labor, and Welfare to sell its biosimilar etanercept biosimilar, LBEC0101.

In December 2017, results of a phase 3 study of LBEC0101 were published in the Annals of the Rheumatic Diseases. The study, conducted in patients with rheumatoid arthritis in 48 centers in Japan and 30 centers in the Republic of Korea, found that the biosimilar had a comparable safety profile to the reference Enbrel, and was well tolerated. Notably, injection-site reactions occurred in fewer patients, and with a lower frequency, in the biosimilar arm of the study than in the reference drug arm.

In addition to its etanercept biosimilar, LG Chem's proposed adalimumab biosimilar, LBAL, is currently in phase 3 development.

Clover to Use GE Platform to Produce Proposed Etanercept Biosimilar

GE has announced that biosimilar developer Clover Biopharmaceuticals will use GE’s biomanufacturing platform, FlexFactory, to produce biosimilars in a new facility in Changxing, Zhejiang, China.

The first biosimilar to be produced using the GE platform is Clover’s SCB-808, a proposed biosimilar etanercept in a pre-filled pen presentation (according to Clover, etanercept biosimilars currently available in China are available only as freeze-dried powder formulations).

Clover reports that the manufacturing facility, which will include two 2000-liter bioreactors, will be up and running by the second half of 2018.

Sandoz Sees Growth for Erelzi in European Union

In its financial report for the fourth quarter of 2017, Sandoz’s parent company, Novartis, called its biosimilars key growth drivers. Sales of the company’s biologics, including biosimilars, reached $309 million during the fourth quarter, due in part to the launch of Erelzi, the company’s etanercept biosimilar, in the European Union.

Sandoz also launched Rixathon, a rituximab biosimilar, in the EU marketplace, and Zarxio, a filgrastim biosimilar, continued to drive growth in the US market.

Sandoz reports, however, that the company’s net sales for the full year were down, as its volume growth of 6% was more than offset by an 8% price erosion, which it says results from “industry-wide pricing pressure” in the United States.