Tag: MabThera

The Biosimilar Mabs Have It: FDA Approves Biosimilars for Adalimumab and Rituxumab

In a busy beginning of the week, the US Food and Drug Administration approved new biosimilars for Humira®and Rituxan®. Samsung Bioepis gained approval for Hadlima™ (adalimumab-bwwd), and Pfizer scored with Ruxience™ (rituximab-pvvr).

HADLIMA

The approval for Hadlima covers the following indications:

  • Rheumatoid arthritis
  • Juvenile idiopathic arthritis
  • Psoriatic arthritis
  • Ankylosing spondylitis
  • Crohn’s disease in adults
  • Ulcerative colitis
  • Plaque psoriasis

Formerly known as SB5, Samsung Bioepis secured Hadlima’s approval on the basis of phase 1 and phase 3 studies in rheumatoid arthritis. The phase 3 investigation included over 500 patients, finding ACR20 responses to be equivalent to that of Humira (at 72%). Immunogenicity profiles for the two agents were also similar through 52 weeks of a switching study.

According to its licensing agreement with Abbvie, manufacturer of Humira, Samsung will not be able to market this agent until end of June 2023. This agent joins Samsung’s two other approved anti-TNF biosimilars, Renflexis (infliximab) and Eticovo (etanercept). Only Renflexis is currently marketed in the US.

RUXIENCE

Pfizer’s newest biosimilar entry, Ruxience, has been approved for a subset of indications of reference product Rituxan, including:

  • Treatment of adult patients with relapsed or refractory, low-grade or  follicular B-cell non-Hodgkin’s lymphoma who are CD20-positive and have failed prior treatments
  • Patients who have nonprogressing, low-grade, CD20-positive B-cell non-Hodgkin’s lymphoma and who are stable after receiving a prior chemotherapy regimen containing cyclophosphamide, vincristine and prednisone
  • Patients with CD20-positive follicular lymphoma who are therapy naïve in combination with chemotherapy or who had responded to previous rituximab therapy
  • Patients with CD20-positive chronic lymphocytic leukemia in combination with fludarabine and cyclophosphamide
  • Granulomatosis with polyangiitis in adult patients in combination with glucocorticoids

The biosimilar does not include Rituxan’s labeled indication for rheumatoid arthritis, similar to the other approved rituximab biosimilar.

The application for Ruxience included the results of the phase 3 clinical trial (REFLECTIONS), which included 394 patients with follicular lymphoma. Compared with the EU-licensed version of rituximab (MabThera®), Ruxience was found to provide equivalent clinical and safety outcomes.

Originally designated PF-05280586, Pfizer has not disclosed when Ruxience will be available. Pfizer signed a settlement with Roche (Genentech) over litigation for a key Rituxan patent, but terms of this agreement were not disclosed. The other FDA-approved biosimilar competitor in this space, Celltrion’s Truxima®, is similarly awaiting launch.

A Profile on Lesser-Known Player in the Biosimilar Space: Archigen Biotech

On occasion, we profile some biosimilar manufacturers about whom our readers may not be familiar. This generally refers to companies that have products that are in earlier-stage research or those who simply have not been in the news as often as their colleagues. In this post, we highlight a joint venture between AstraZeneca and Samsung BioLogics, Archigen Biotech Ltd.

Archigen BiotechEstablished in 2014, Archigen has focused on the development of a single biosimilar drug, SAIT101, which will compete in the rituximab space against the likes of Rituxan® and MabThera® (and perhaps other approved rituximab biosimilars). According to a 2016 report, Samsung Electronics had initially sought to develop this agent in 2012, but abandoned the effort soon afterward because of lack of capital.

One of the partners, Samsung BioLogics, also has a stake in Samsung Bioepis (with Biogen). Archigen says on its website that it will be relying on “leading global Contract Research Organizations and Contract Manufacturing Organizations to ensure efficient execution of drug development activities.”

Why you may be hearing more about this company: Its phase 1 study of SAIT101 was implemented October 2016, and clinical results should be available soon. This study was conducted with 246 patients with rheumatoid arthritis, testing the drug against both reference drugs, and included a switching arm. This is unusual for both the size and extent of a phase 1 investigation. Additionally, the organization did not conduct a separate drug trial in healthy volunteers, which is often a first step in analyzing the medication’s pharmacokinetics and pharmacodynamics. Instead, Archigen is moving directly to a phase 3 trial in patients with follicular lymphoma. This study started in January 2017, with initial results expected in May 2019. The phase 3 trial will have over 300 patients, and use MabThera as the comparator.

Based on these dates, a 351(k) filing could be achieved as early as the fourth quarter of 2019, with potential approval in the third quarter of 2020.

Archigen Biotech has not posted on its website any information about subsequent drug targets. Indeed, its website is sparse. It is possible that following the clinical development of SAIT101, Archigen will be more focused on new branded agents, leaving Samsung Bioepis to work on its biosimilar portfolio.