JHL Forges Ahead With Phase 3 Study of Embattled Rituximab Biosimilar

Chinese drug developer JHL Biotech has announced that it randomized its first patient in a phase 3 study of JHL1101, a proposed biosimilar rituximab referencing Rituxan.

The phase 3 study in diffuse large B-cell lymphoma (DLBCL) is a multinational, randomized, double-blind, positive-controlled, parallel-group clinical trial comparing the efficacy and safety of the proposed biosimilar with that of the reference, both in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). JHL indicated that it will seek approval of indications for the treatment of rheumatoid arthritis as well as of lymphomas.

When announcing the trial, Racho Jordanov, chief executive officer of JHL Biotech, said in a statement, "Rituximab is an important biologic for the treatment of lymphoma and rheumatoid arthritis. Unfortunately, it is very expensive for patients and healthcare payers. JHL1101 would provide an affordable treatment for these patients. This is a significant milestone for JHL, and a step forward in our goal to become a global leader in developing, manufacturing, and commercializing biologics."

JHL indicated that the trial would be conducted in Europe, China, and other Asian nations. The announcement of the first randomization follows a July 2018 receipt of positive scientific advice from the European Medicines Agency’s Committee for Medicinal Products for Human Use that allowed the drug maker to move forward with its study in Europe.

Announcement of the phase 3 trial comes as JHL is facing serious scrutiny of its biosimilar programs after it was revealed that several of its employees, all former staffers of the Roche subsidiary Genentech, had been indicted in the United States in connection with the theft of trade secrets related to reference biologics.

According to an October statement issued by the United States Attorney’s Office in San Francisco, California, Xanthe Lam, a principal scientist at the Roche, conspired with her husband and fellow former employee Allen Lam, as well as with John Chan, another former employee, to steal Roche and Genentech’s information related to the reference rituximab, as well as several other biologics.

Genentech has filed a motion in the United States district court for the Northern District of California seeking an injunction to block JHL from making or selling any of the proposed biosimilars for which the indicted parties allegedly stole information, as Genentech alleges that JHL wrongly benefitted from its proprietary data.

If convicted of stealing trade secrets in order to funnel them to JHL for the development of biosimilars, the former Genentech workers each face as many as 10 years in prison.