New era about to dawn: Novartis, and now Celltrion, present biosimilars to the FDA

Biosimilars hold huge promise, with estimates for this decade running from $35 billion to $200 billion and growing exponentially from there. And of course the U.S., being the world's largest pharma market, presents the greatest potential, once someone breaks in and acceptance can be judged. Two baby steps in the last two months are starting that process, with Novartis ($NVS) filing the first biosimilar application with the FDA last month and Celltrion following this week with the first app for a biosimilar of a MAb, or monoclonal antibody.

The South Korean company, which hopes to be a biosimilar powerhouse, tipped its hat to Novartis' Sandoz unit Tuesday for being first, when it announced it had filed its application for Remsima, a biosimilar of Remicade, the blockbuster anti-inflammatory treatment sold by Johnson & Johnson's ($JNJ) Janssen Biotech division. Novartis last month filed the first application for a biosimilar of Neupogen, Amgen's ($AMGN) white blood cell booster for cancer patients.

Remicade brought in $8.4 billion last year, which goes a long way to explaining the reason so many companies hope to eventually get biosimilars to the market and why payers are anxious for them to do that. Biologics are among the most expensive drugs on the market. While biosimilars are not expected to have the financial impact of small-molecule generics, whacking out 80% or 90% of a branded drug's sales, they will save patients and payers significant sums, while still earning big bucks for their developers.

But that requires approval and acceptance, and Novartis and Celltrion are blazing the path there. Celltrion and partner Hospira ($HSP) got approval last year in Europe for the Remicade biosimilar, called Inflectra there. But after consultations with the FDA, Celltrion it said it decided to do another 6 months of clinical trials to show its bioequivalency with Remicade before filing its application. It said Tuesday that it expects FDA approval within a year.

But then comes the questions of use and uptake. Biosimilars have been in use in Europe for more than 5 years but so far they haven't sold that well. That appears to be because doctors are just not as comfortable with these cheaper versions of cell-based drugs as they are with knockoffs of small-molecule drugs. Norway has even decided to fund its own trial comparing Hospira and Celltrion's Inflectra with Remicade, in hopes of proving to the medical profession that biosimilars are as effective as their counterparts.

And it is not as if drugmakers whose products are targets are going to just roll over for the new competition. Janssen has patents on Remicade in the U.S. to 2018, but Celltrion says it is challenging that in court.

But lots of drugmakers are watching closely what happens next for Novartis and Celltrion. A number of top-selling biologics, including Herceptin, Humalog and MabThera, will lose product patent protection over the next 5 years. Many of these are blockbusters and have already been targeted by companies hoping to cash in on worldwide demand for life-extending biologics and the growing frustrations over the prices they command.

- here's the Celltrion statement
- read the PharmaTimes story

Related Articles:
Norway to compare Hospira knockoff with J&J's Remicade to goose biosimilars market
Hospira, Celltrion achieve milestone in EU with OK for Remicade biosimilar
Mylan, Biocon ready to roll out Herceptin biosimilar in India
Teva, Lonza end biosimilars joint venture as the copycat crowd thins

Suggested Articles

The future may be uncertain for AZ’s Imfinzi in first-line lung cancer, but its targeted med Tagrisso now boasts a green light in that setting.

Ultragenyx is back with another FDA nod, this time for Crysvita to treat X-linked hypophosphatemia in patients one year and older.

Roche got a two pieces of good Hemlibra news early this week—and what's good for Hemlibra must be good for Roche.