Novartis’ Sandoz unit is not resting on its laurels after being the first company to gain U.S. approval for a biosimilar last year as it announced that the EMA has accepted for review its copycat version of Roche’s major blockbuster cancer/autoimmune drug Rituxan.
Rituxan (rituximab)--also known as MabThera--is currently Roche’s ($RHHBY) biggest-selling drug, raking in just over $7 billion in sales last year--but it looks as if it will start to see this revenue hit in Europe as the EMA has now accepted Novartis’ ($NVS) rituximab biosimilar for review.
MabThera, as it is called outside of the U.S., is currently licensed in Europe to treat certain forms of non‑Hodgkin’s lymphoma and chronic lymphocytic leukaemia, as well as severe rheumatoid arthritis and two forms of severe vasculitis. Novartis, which is developing its copycat through its biosimilars unit Sandoz, said it is “seeking approval for all indications included in the reference product's label.”
"Patients with hematologic or blood cancers and rheumatoid arthritis, as well as their doctors, often have few treatment options and have long relied on rituximab as a vital part of their treatment," said Richard Francis, Division Head and CEO of Sandoz.
"If approved, we believe our biosimilar rituximab will help broaden access to this important therapy and liberate healthcare resources that can be used to fund other innovative medicines." A price tag for the treatment has not yet been released, but many biosimilars are typically anywhere from 10 – 25% cheaper than the originator product.
Sandoz said in a statement that it believes the “totality of data in its submission will demonstrate that our biosimilar rituximab has essentially the same biological substance as, and the final drug product is highly similar to, the reference product.”
In addition to analytical, functional and preclinical data, the Sandoz said its submission includes data from two pivotal confirmatory safety, PK/PD and efficacy studies that involved 629 follicular lymphoma and 173 rheumatoid arthritis patients. It did not specify details on the trials’ outcomes.
Back in January, Sandoz also signed an exclusive license agreement with Kyowa Hakko Kirin for the distribution and promotion of rituximab in Japan.
It looked as if Sandoz would be the only player in the rituximab biosim field when last fall Germany’s private pharma co Boehringer terminated the development of its biosimilar rituximab programme, following similar announcements from Teva ($TEVA), Merck ($MRK) and Samsung Bioepsis.
In 2013 Korea’s Celltrion also killed off a Phase III trial that planned to compare biosimilar rituximab with MabThera, both in combination with cyclophosphamide, vincristine and prednisone, in patients with CD20+ follicular lymphoma.
But in a twist, Celltrion’s CT-P10 has--according to reports in Korea at least--also now been submitted for approval in Europe--although the company has not publicly provided any trial data for the submission, or whether it is going for all or just some of the originator’s indications.
Novartis recently split its pharma and oncology divisions and saw no place for its former pharma chief David Epstein, and has been struggling to grow its Alcon eye-care unit, but has been increasingly focused on biosimilars--notably so since the FDA’s approval of Zarxio, its copycat of Amgen’s ($AMGN) Neupogen, last year.
Just this week Samsung Bioepis, a JV between Korea’s tech giant Samsung and Biogen ($BIIB), announced that the FDA had accepted for review its biosim of Janssen’s ($JNJ) blockbuster Remicade (infliximab).
Last month, its native Korean rival Celltrion was granted FDA approval for its Remicade copycat infliximab-dyyb.
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