Abbvie’s biosimilar fight over Humira patent highlights differences between EU and US regulatory mindsets

3dman_eu / Pixabay

The News:

Coherus BioSciences Inc. (Redwood City CA) last week announced that the Patent Trial and Appeal Board (PTAB) of the US Patent and Trademark Office ruled in the company’s favor in a challenge over AbbVie Inc.’s (North Chicago) Humira (adalimumab) by invalidating all claims of a patent covering the drug.

@USPTO ruled in favor of Coherus BioSciences in a challenge with @AbbVie Click To Tweet

Denny Lanfear, CEO of Coherus, which has been seeking to launch its proposed Humira biosimilar CHS-1420, said “while more remains to be done, this is a significant step forward to lowering drug costs for patients and healthcare providers in the US system.”

Specifically, Coherus explained that the claims of the so-called ‘135 patent were directed to a method for treating rheumatoid arthritis by administering Humira subcutaneously every 13 days to 15 days.

“We will continue to aggressively press forward with the development and commercialization of our CHS-1420 [Humira] biosimilar,” remarked Lanfear.

Meanwhile, AbbVie stated it was “disappointed” by the PTAB decision, adding that it intends to appeal the ruling. Last month, the company reported that sales of Humira in the first quarter climbed by 15.1% to $4.1 billion. The therapy accounted for 63% of AbbVie’s revenue in 2016.

Leerink analysts recently suggested that “the hurdle for any biosimilar company to launch a biosimilar Humira by 2019 is still high, and given AbbVie’s extensive patent estate extending into the 2030’s, any biosimilar challenger must be willing to undertake an at-risk launch until further patents are invalidated through the [inter partes review] process or the federal circuit courts.”

Last September, the FDA approved Amgen Inc.’s Humira biosimilar Amjevita (adalimumab-atto) for multiple inflammatory diseases. Prior to the FDA’s decision, AbbVie had filed a patent infringement lawsuit in the US seeking to block Amgen from marketing its biosimilar product, and the case remains pending. The European Commission also recently approved Amjevita for the treatment of certain inflammatory diseases.

Steve’s Take:

Few drugs at­tract the kind of at­ten­tion from the biosim­i­lars crowd that Hu­mira merit. Ab­b­Vie gets the lion’s share–63%, in fact–of its rev­enue from this $16 bil­lion colossus and the bio­pharma com­pany has sworn to guard its patents with a le­gion of the best paid at­tor­neys in the field.

But the gener­ics throng con­tin­ues to chip away at the foundation of its intellectual property, says EndPoints.

Last week Co­herus Bio­Science scored a key win in its on­go­ing bat­tle to mar­ket a copy. The US Patent and Trade­mark Of­fice’s Patent Trial and Ap­peals Board ruled in its favor on one of a set of patents.

Leerink’s Ge­of­frey Porges looked it over and con­cluded that Co­herus or Boehringer In­gel­heim GmbH just may get to start mar­ket­ing their biosim­i­lar in 2019 in­stead of the con­sen­sus es­ti­mate of 2020. And that’s a big deal that could ac­cel­er­ate de­vel­op­ment ef­forts on an imitator that could pass muster on the patent (legal) side. But it won’t be easy.

The decision in favor of Coherus highlights the evolving nature of biosimilars in the drugs market and the different regulatory mindsets the EU and US have brought to the market for these white-hot medicines.

FirstWord Pharma points out that within the next decade, patents on some of the most widely used biological medicines are scheduled to expire in the EU and US. This will pave the way for new biosimilars from both big pharma and smaller upstarts to enter–and potentially transform–this lucrative market.

Quick history lesson

When biological medicines first entered the market some 25 years ago, they represented the cutting-edge of biomedical research. Since then, biologics have transformed the treatment of a number of conditions that previously had limited–and, in some cases, no–treatment options.

These therapies, which are defined as any pharmaceutical drug product manufactured in, extracted from or semi-synthesized from biological sources, had a total global market value of $161 billion in 2014, and this is expected to increase to an astonishing $390 billion by 2020.1

Regulatory environment: Europe leaves the US in its dust

In 2006, the European Medicines Agency (EMA) approved its first biosimilar, Sandoz’s (Novartis) Omnitrope (somatropin). In the years since, the regulator has approved a total of 23 biosimilars within the product classes of human growth hormone (hGH), granulocyte colony-stimulating factor (GCSF, which stimulates the bone marrow to produce and release granulocytes and stem cells), erythropoiesis-stimulating agents (erythropoietin analogues used to treat anemia), insulin, folliclestimulating hormone (FSH) for reproductive procedures, and tumor necrosis factor (TNF) inhibitor (which suppresses the immune system in inflammatory and autoimmune diseases).

Currently, it takes an average of 15 months for an application to market a new biosimilar to be reviewed in the EU; a further two or so months is then taken for the European Commission (EC) to formally approve the new therapy.

The FDA, meanwhile, has lagged significantly behind the EU in terms of approving biosimilars. Nine years after the EMA’s first approval the US regulator finally granted its first marketing authorization–for Sandoz’s Zarxio (filgrastim-sndz)5 in March 2015–and has approved only one other biosimilar application, for Celltrion’s CT-P13 (infliximab), which will be marketed by Pfizer in the US as Inflectra,6 in the months since.

Pricing and reimbursement

One of the most appealing aspects of biosimilars is their potential to lower healthcare costs by being priced at a significant discount to their originator therapies, making them more accessible to patients with limited resources. Specifically, analysts suggest that over the next five years, the combined savings in the EU5 (Germany, France, Italy, Spain and the UK) and US could range from $55 billion to as much as $110 billion.

Payer perception wins the day

FirstWord research finds that payers view price as the primary driver of biosimilar use. Specifically, they believe that biosimilars offer a solution to increasing demands and limited resources, as well as a significant opportunity to provide enhancements in care by making biopharmaceuticals, which could be out of the reach of some patients due to their price point, available to the masses.

Bottom Line:

Put succinctly, the EU prizes speed getting biosimilars to its citizens at the lowest possible cost. On the other hand, the US has focused more on protecting patentholders’ lucrative marketshare position, but that mindset is slowly moving toward that of the EU.

Steve's Take: @USPTO should adopt Europe's speedier #regulatory path for #biosimilars Click To Tweet

The deluge of upcoming patent expiries will test the US’s resolve to either get biosimilars to market quickly and cheaply or more slowly with an eye on preserving patentholders’ market advantage. The current administration will be torn between these two competing interests and only time will tell which side it will favor.

(Reference: FirstWord Perspectives: The State of Biosimilars. March 2017 (pdf))