The News:

Amgen Inc. (Thousand Oaks CA) and Allergan PLC (Dublin IRL) said Thursday (September 14, 2017) that the Food and Drug Administration has approved their Biosimilar version of Roche Holding AG’s (Basel CHE) Avastin for five types of cancer.

The drug, Mvasi, is the first anti-cancer biosimilar drug approved and the first biosimilar of Avastin, according to Morningstar. Mvasi was approved for squamous non-small cell lung cancer, metastatic colorectal cancer, glioblastoma, metastatic renal cell carcinoma and persistent, recurrent, or metastatic carcinoma of the cervix.

Biosimilar drugs essentially replicate existing biologic treatments but at lower prices, and are expected to save the US healthcare system as much as $250 billion over the next 10 years, according to MarketWatch.

Roche shares closed Thursday up unchanged at 244.00 Swiss francs; Allergan slipped 1% to $223.70 in New York; and Amgen was unchanged at $189.44.

Steve’s Take:

Did you happen to catch the score? The US is down 2-20 against the EU. That sounds like an unfortunate soccer season, with the US in last place (or headed toward the worst single-game defeat in US history). Regrettably, this is not a sporting event. I’m talking about Biosimilars, and the US is seriously lagging as the EU took a 16-point lead earlier this spring.

Currently, the FDA has scored 5 more biosimilars compared to the 28 now approved by the EMA for patients in Europe. The first US biosimilar launched in 2015, and Amgen and Allergan’s Avastin biosim is the most recent. The EU approved its first biosim way back in 2006. So, it may be late in the game, but not too late for an historic comeback.

As explained by FiercePharma,

“Initially, from the payer perspective, biosimilars were expected to generate 30% to 40% savings compared to existing treatments.”

The pharmaceutical industry is continually challenged internally to reduce production costs, but also externally to provide affordable alternatives that reduce costs for patients. Since biosimilars seem like a promising solution, the vexing question is: why have only 7 biosimilars been approved by the FDA?

According to FiercePharma, here’s the problem:

“As the complexity of bringing biosimilars to market continues to be discussed, more recent data suggest that most payers anticipate a biosimilar will come in between 10% to 20% less than the cost of the branded manufacturer. In Europe, we know that biosimilars have often been just a 10% discount from the brand.”

“There is more than meets the eye,” says Emilie Liadis for Doe & Ingalls. “Right now the industry is balancing a wide range of different concerns from patient safety to costs, processes, and more. That seems to be what the FDA is waiting on. Do they want more data? How many have they denied?”

Leah Christl, PhD, Associate Director for Therapeutic Biologics at FDA predicts,

“Biosimilars are likely to create greater competition in the medical marketplace. The potential of this market is going to drive growth and increase competition. All of these things are good for the patient and good for manufacturers. This will result in increased treatment options for consumers, which will ultimately lead to more affordable alternatives.”

Seeing potential, the industry has the pedal down as many companies scurry to develop new biosimilar treatments.

Bringing such drugs to market quickly is key to FDA Commissioner Scott Gottlieb’s plan for lowering drug and healthcare costs.

“Bringing new biosimilars to patients, especially for diseases where the cost of existing treatments can be high, is an important way to help spur competition that can lower health care costs and increase access to important therapies,” Gottlieb said in a press release.

Avastin can cost $6,100 to $12,300 a month, depending on the type of cancer. An Amgen spokeswoman said the company is “not providing launch details or pricing information at this time.”

Branded drugmakers have argued that biosimilars are not identical to the reference drugs because of the complexity of manufacturing biologics built from living organisms. As a result, they have argued for labeling, pricing and using biosimilars differently.

While pursuing biosimilars, Amgen also is one of the biggest developers of branded biologics. So, while its branded drugs are being challenged by–and Amgen is fighting–biosimilar developers, it is trying to make money off the mirror-image drugs, too.

Ironically, and sadly for Roche, the same day that the advisory committee considered Amgen’s drug, it voted 16-0 in favor of a biosimilar of the Swiss titan’s Herceptin from Mylan NV and partner Biocon Inc.

That was also slated to get an FDA decision this month but Biocon recently reported that the FDA told Mylan it was extending the target action date for their Trastuzumab application to Dec. 3 in order to review some “clarificatory information.” Biocon said in the filing that the extension would not affect its timetable for getting the product to market in the US.

Amgen has been on both sides of these contests having its Humira knockoff considered similar enough to the original AbbVie Inc. biologic to be approved recently for essentially all uses of Humira. As of 2008, adalimumab had been approved by the FDA for the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, moderate to severe chronic psoriasis and juvenile idiopathic arthritis.

Amgen’s long-shielded Enbrel (etanercept) is slated to finally see biosimilar competition in 2029 if all its various “submarine” patents hold. Amgen’s (darbepoetin alfa) patent runs to May 2024.

Bottom Line:

As I’ve said quite often in the past, Dr. Gottlieb is the right person at the right time to address this urgent need here in the US to bring down the cost of pharmaceuticals. So far, he’s been one of the few (or maybe the only) appointee in the Trump administration the Oval Office chief hasn’t trashed in a Tweetstorm or fed to the Capitol Hill mainstream media wolves.

Steve's Take: I'm confident that @SGottliebFDA will narrow the US #biosimilar gap with the EU
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Let’s just hope Mr. Trump continues to let his FDA chief continue to do the job he’s so uniquely qualified to do—-for us citizens out here. And, don’t think that lopsided biosimilar score with the EU won’t narrow sharply under Gottlieb’s coaching.

For you sports fans out there, just contemplate UCLA’s recent comeback from a 34-point deficit late in the third quarter against Texas A&M at the Rose Bowl. Dr. Gottlieb, you can do it, too.