The FDA has accepted Korea-based Samsung Bioepis’ biologic copycat of Janssen’s blockbuster autoimmune drug Remicade (infliximab)--a month after the U.S. regulator granted approval to Samsung’s native rival Celltrion for its version of the drug.
Samsung Bioepis said in a statement that the FDA has accepted its BLA for SB2--a biosimilar candidate of Johnson & Johnson’s ($JNJ) Janssen drug unit’s Remicade (infliximab), for the treatment of: rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and psoriasis. Remicade made $6.6 billion last year.
This comes off the back of the drug winning a positive opinion from Europe’s CHMP in April as “Flixabi”, and now awaits European Commission approval--which should be granted this quarter. It is already sold in Korea as Renflexis.
SB2 is the first Samsung biosimilar submitted for review in the U.S. But if approved, the marketing and distribution of the drug in the country will in fact be handled by its partner Merck ($MRK), under a sales deal the two signed back in 2013. Samsung Bioepis was created back in 2012 and is part of a JV between Biogen ($BIIB) and Samsung.
The BLA for SB2 was based on Phase I and Phase III studies that tested the biosimilarity of SB2 to Remicade.
In a 54-week Phase II clinical study, the treatment showed comparable safety and equivalent efficacy to Remicade, as shown in ACR20 response rate of 65.3% in the SB2 arm versus 69.2% in the Remicade arm at week 54, supporting the 30-week study results of 64.1% and 66%, respectively.
The SB2 study randomized 584 patients with moderate to severe rheumatoid arthritis despite methotrexate therapy across 73 sites in 11 countries, according to the Korean company.
But Samsung is playing catch-up with native Korean rival Celltrion, which last month was granted FDA approval for its Remicade copycat Inflectra (infliximab-dyyb).
The drug will be marketed by Pfizer's ($PFE) Hospira unit, which has rights in the U.S. On the first quarter earnings call, a Pfizer exec cautiously said the drug should be on the market by July.
Janssen has said however that, given the ongoing legal spats over the drug, it will likely not be launched in the U.S. until at least next year. This was the case with Novartis’ ($NVS) Zarxio (filgrastim-sndz), a copycat of Amgen's ($AMGN) Neupogen--the first ever approved biosimilar in the U.S.--but one that had to wait 6 months to launch because of legal delays.
There still remains many teething problems with the FDA and this new process--which only began with the first approval for a biosimilar last year--including the naming of the copycats and how their labels should be written.
Biosimilars have been available in Europe for a decade, with Remicade copies also already available in the EU--but the U.S. has been much slower to allow the introduction of the drugs.
But since the launch of Zarxio last year the door has been pushed ajar for these copycat firms, and there’s much more waiting in the wings from the tech giant’s biotech arm, which is touting 13 biosimilar candidates, all for some of the biggest-selling drugs of all time.
These include: Amgen’s ($AMGN) autoimmune drug Enbrel (etanercept); AbbVie’s ($ABBV) Humira (adalimumab); Sanofi’s ($SNY) Lantus (insulin glargine); and Roche’s multi-licensed cancer drug SB8 Avastin (bevacizumab). Collectively, these drugs made around $33 billion in sales last year.
Many other companies, including Novartis’ Sandoz unit as well as Celltrion are also seeking to develop and sell biosimilars of these meds, which could see the patented drugs’ sales decimated or worse, given that many biosimilars are around 10 – 25% cheaper than their originator products.
Uptake has sometimes proven slow with biosimilars, but with a major drug pricing debate bubbling in the U.S., and a cash conscious Europe, healthcare payers are expected to become more amenable to these new drugs if they represent a significant saving, and can be used safely and effectively.
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