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Opinion

Roche tops biosimilar defence league by a 'country mile'

Dan Stanton

By Dan Stanton+

08-Mar-2017
Last updated on 08-Mar-2017 at 15:20 GMT2017-03-08T15:20:15Z

Image: iStock/hkratky
Image: iStock/hkratky

Roche is better positioned than Amgen, AbbVie and Janssen to defend against biosimilar competition, according to this writer and a Twitter poll.

Which innovator is best positioned to defend against #biosimilar competition?

That was the question recently posed on Twitter , and from the 102 responses 39% said Swiss Biopharma Roche (and its Californian subsidiary Genentech) was best placed, followed by Amgen (27%), AbbVie (22%) and finally Johnson & Johnson (12%).

Roche: R&D and reformulations

As anyone who follows @realDonaldTrump knows, opinions on Twitter may not be fully substantiated.

But at least this reporter’s take that Roche was by far the best placed was supported by fellow journalist and biosimilars expert Duncan Emerton who cited the firm’s portfolio was broader and more balanced than the others.

And according to Roche spokeswoman Ulrike Engels-Lange, a wide product portfolio and strong pipeline are key to protect the firm’s top-line from biosimilar erosion. Roche has recently launched “an unprecedented” four new medicines and “received 14 FDA Breakthrough designations, more than any pharmaceutical company,” she told us.

“Our focus has been and will continue to be on delivering innovative medicines and diagnostics to patients across the world. Our core mission will not change as we are continuously finding new healthcare treatments and solutions that improve and transform patients' lives.”

Roche has also been defending against potential biosimilar competition by developing new formulations or device-combinations of some of its top-selling biologics, including Herceptin (trastuzumab) and Rituxan (rituximab).

AbbVie: Court in the action?

Neither second-place Amgen nor third-place AbbVie commented on the poll results when asked, or gave up further information to Biopharma-Reporter on their defence strategy.

However, AbbVie has repeatedly said it believes its extensive estate of approximately 70 formulation, manufacturing and method-of-action patents on Humira (adalimumab) will keep erosion of its sales – standing at $16bn worldwide last year – at bay.

But AbbVie has been involved in several law suits, the latest brought on in the UK by biosimilar developers Samsung Bioepis and Fujifilm going against the firm this week. While the court decision will not erode Humira’s many layers of protection, an IP lawyer told us it could lead AbbVie to rethink its protection strategy.

Amgen: Cake and eat it?

Amgen, meanwhile, has already suffered major revenue loss (outside the US at least) from an influx of first-wave biosimilars – versions of Neupogen (filgrastim) and Epogen (epoetin alfa) for example – and is now trying to defend against versions of Enbrel (etanercept) from companies including Sandoz and Samsung Bioepis .

But Amgen has chosen to play the game from both sides. While defending its own biologics portfolio, it has seen success in getting a biosimilar version of Humira – named Amjevita – approved in the US , and is consequently battling AbbVie over IP.

And, with a further eight biosimilars in its development pipeline, it seems well-placed to offset some of its reference drug losses when the biosimilars market fully blooms.

Similarly Pfizer – not part of the poll – is both competing in and defending against the biosimilar sector and is looking to harness expertise and capabilities garnered in its originator biologics business to bolster its biosimilar dominance.

“Biosimilars are actually a great example of leveraging the strength and capabilities across the whole Pfizer organisation in cell line development and biologic manufacturing to create more affordable patient access and to create what we believe will be a significant commercial opportunity,” Pfizer group president John Young said at the Cowen and Company 37th Annual Healthcare Conference yesterday.

J&J: Remicade

J&J’s place at the bottom of the poll reflects the growing number of biosimilar versions of its bestselling autoimmune mAb Remicade (infliximab). Pfizer, Celltrion, and Samsung Bioepis have versions approved in various markets, and a number of other firms are developing their own molecule.

But J&J and its subsidiary Janssen are rather less concerned about biosimilar sales erosion than its peers, according to management in a number of investor calls.

In some markets, heavy discounts on infliximab biosimilars have essentially wiped out sales of the reference drug , but despite this J&J recently said it expects no more than a 15% impact from biosimilars on 2017 Remicade sales. 2016 sales stood at $4.45bn.

And according to a statement sent to this publication, the firm will rely on Remicade’s reputation along with the fact no biosimilar infliximab has so far been deemed interchangeable with Remicade to ensure such a low impact:

“Physicians trust the safety and efficacy of Remicade, which has a well-established profile developed through extensive clinical research programs, post-marketing surveillance, patient registries, and commercial experience over the past 22 years.”

Defenceless

Of course, there is the possibility that none of the four reference drugmakers, nor any other innovator, will be in a position to stop the influx of biosimilars as one respondent suggested:

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