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Biosimilar Reports – May 2017

Biosimilars continue to command a great deal of research, development and attention given the promise of significant cost savings and potentially wider use for those in need. Biosimilar Reports is an ongoing series dedicated to advances, discussions and developments in biosimilar agents intended for use by rheumatologists.  

RheumNow provides review this subject with updates, news, new publications, overview articles, clinical trial results, regulatory and legal issues impacting to biosimilar development and use. Many of these items were compiled from news sources, journal articles and regulatory documents and are cited and linked within each section.  


  • Renflexis (Infliximab-abda) was FDA approved on 21 April 2017, making it the 2nd infliximab biosimilar to hit the market.  It is manufactured by Samsung Bioepis and in developmental trials was called SB2. Renflexis will carry the same indications of the originator (Remicade) including active, moderate-severe, rheumatoid arthritis, ankylosing spondylitis, adult and pediatric Crohn’s disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis. It also comes with the same boxed warnings and dosing as the originator, infliximab. It will be marketed and distributed in the United States by Merck & Co Inc.

Anti-TNF Inhibitor Biosimilars Approved in between April 2016 – April  2017

Anti-TNF Inhibitor Biosimilars Approved in between April 2016 – April  2017





Generic (+suffix)






Infliximab -dyyb

April 2016




Sandoz/ Novartis


August 2016






Sept 2016






April 2017








 Clinical Trials & Journal Articles

  • Glintborg et al reported the results of the DANBIO non-medical switch from originator infliximab to biosimilar CT-P13 in 802 inflammatory arthritis arthritis patients with RA, PsA, AxSpA who were previously treated with reference infliximab (INX) for 6.8 years. They found that non-medical switch to CT-P13 had no greater flare rates or withdrawals than those on INX. 132 patients withdrew (lack of effect 54% or adverse events 28%). Patients with previous INX treatment duration >5 years had longer CT-P13 retention.
  • NOR-Switch Study. Lancet published the results of the NOR-SWITCH study - a study designed to assess the efficacy and safety of transitioning from the originator (Remicade) to the less expensive biosimilar CT-P13 (Remsima/Inflectra) in the treatment of Crohn's disease, ulcerative colitis, spondyloarthritis, rheumatoid arthritis, psoriatic arthritis, and chronic plaque psoriasis. NOR-SWITCH was a phase IV, 52 week, randomized, non-inferiority, double-blind trial with 52 weeks where 482 patients (on stable Remicade) either continued infliximab originator or switched to CT-P13 treatment, with the primary endpoint was disease worsening. No significant difference in disease worsening was seen (26% in the originator group and 30% in the biosimilar group), thus meeting the definition of noninferiority at 52 weeks. This trial was powered to assess noninferiority for all conditions combined and not individual disorders. Adverse events were similar between groups.
  • GP2017 ADA Biosimilar in Psoriasis. In March 2017 Sandoz presented data at the American Academy of Dermatology in Orlando, Florida on its Phase 3 trial of its biosimilar adalimumab (GP2017) compared to reference adalimumab (Humira). This 51-week trial met its primary endpoint demonstrating equivalent efficacy of GP2017 to Humira. At week 16, PASI75 response rates were 67% vs 65% for GP2017 vs adalimumab respectively.
  • Lichenoid Eruption with Biosimilar Switch. There is a report of a single case of a lichenoid eruption induced by biosimilar Infliximab switching; occurring several days after her initial infusion of the biosimilar.
  • Rituximab biosimilar CT-P10 being developed. A budget analysis for use in 28 EU countries shows introduction of CT-P10 was associated with projected savings of €90.04 million in the first year, which would allow 7531 additional patients to access rituximab treatment.

Overviews & Reviews

  • Biosimilar interchangeability explained. reviews interchangeability. The Biologics Price Competition and Innovation Act of 2009 defines an interchangeable biosimilar is one that “may be substituted for the reference product without the intervention of the health care provider who prescribed the reference product.” To be interchangeable, a biosimilar meet additional regulatory standards beyond being “biosimilar” to the reference product. The new draft FDA guidance on interchangeability require a “dedicated switching study” and the “switching” group would be expected to incorporate at least three switches between the reference and biosimilar products. For more:
  • Review of Biosimilar Process. A review of the technicalities, characterization, regulations, and clinical trial outsourcing options. The Association for Accessible Medicines (AAM) claims that “there is a misconception that clinical trials will assure the safety of biosimilars, when instead, analytical comparisons will be the most powerful tool in determining whether a biosimilar is ‘highly similar’ to its reference product.

Practice & Physician Attitudes

  • DDW Address on Biosimilars. Reviewed the growth of biosimilars. The law in at least 12 states specifies individual patients must be notified that a substitute or switch of medications has been made, Some state laws requires that the patient consent to the switch before any such switch is made. A survey by the European Federation of Crohn’s and Ulcerative Colitis Associations showed that  patients who have heard of biosimilars but were not being treated with them, 47 percent worried about the safety profile of the agents, 40 percent worried about their efficacy, 56 percent thought the lower cost of biosimilars should not come before their safety and efficacy/ 

 Patient Education

Regulatory & Pharma

  • New Biosimilar Guidelines. The European Medicines Agency (EMA) has published new guidelines on biosimilar use for healthcare professionals. The goal is to provide healthcare professionals with reference information on both the science and regulation underpinning the use of biosimilars. The guide was developed by the EMA and European Commission in collaboration with EU scientific experts.
  • CMS Urged to Change Biosimilar Reimbursements. The current CMS rule was issued in October 2016 and requires all biosimilars, related to a reference product, to be given a shared Healthcare Common Procedure Coding System (HCPCS) code. For Medicare Part B, reimbursement is then calculated based on the average sales price (ASP) of all of the biosimilars with that HCPCS code plus 6% of their reference product’s ASP. There is bipartisan lobbying to change this as not all biosimilars should be similarly priced.
  • Advisory Committee Recommends Epoetin Biosimilar. On 5/25/17, the FDA’s Oncologic Drugs Committee voted 14-1 today to recommend approving a biologics license application for epoetin alfa (Epogen/Procrit) biosimilar manufactured by Hospira.
  • ACR Responds to FDA Draft Guidance on Biosimilar Interchangeability.  ACR President, Dr. Sharad Lakhanpal, has issued a statement in support of the FDA draft on interchangeability. The ACR also supports the FDA naming suffixes and the Biosimilar User Fee Act.  The ACR does not support extrapolation, but believe that it “should be rigorously studied and fully utilized to help reduce the cost of these drugs”.
  • CHMP in the EU has recommended Sandoz biosimilar versions of rituximab and etanercept for approval by the EMA. EMA decision awaited 

Legal Issues


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