FDA Approves 6th Biosimilar in US, Second for Humira

Regulatory NewsRegulatory News
| 28 August 2017 | By Zachary Brennan 

The US Food and Drug Administration (FDA) announced Friday that it has approved Boehringer Ingelheim’s Cyltezo (adalimumab-adbm), the second biosimilar to AbbVie’s blockbuster Humira (adalimumab).

Cyltezo, which follows the approval of Amgen's Amjevita (adalimumab-atto) last September, has been approved for multiple indications (see link to label below), did not go before an FDA advisory committee and was not approved as an interchangeable biosimilar.

However, Humira, which has brought in tens of billions in sales since it first won approval from FDA in 2002, will not likely see biosimilar competition in the US market for at least another couple of years because of patent litigation. In the EU, Humira biosimilars were approved last March.

Analyst Biosimilar Predictions

Bernstein biotech analyst Ronny Gal told investors in a note sent Friday that the adoption of biosimilars in the EU “continues to surprise to the upside” as member states have increased their adoption. 

“Prices are lower (say ~50% discount of pre-biosimilar entry) and the commercial model is supported by very light marketing requirements. Further, the number of late-stage competitors in key markets (Enbrel, Epogen, and Remicade) is only 3-4, suggesting continuation of profitability. The big upcoming test is the adoption of the oncology products (Rituxan launched and Herceptin expected). Neulasta will presumably launch in 2018 and will do very well in the EU markets,” Gal wrote.

For the US marketplace, however, Gal points to “two key speed bumps”: Approvals of Epogen and Neulasta have been delayed for a year and the Remicade biosimilars approved in April 2016 and last April have “failed to gain traction, exposing some weaknesses in the US market when it comes to encouraging biosimilars and casting doubt on the market,” though he expects this to change in the next 12 months.

In terms of other predictions, Gal said Epogen and Neulasta biosimilars will launch in the US though he expects “relatively weak adoption” before the end of 2018. 

He also predicts that at least five third-wave biosimilar programs will begin clinical trials, including those for biosimilars to Biogen’s Tysabri (natalizumab), Bristol-Myers Squibb’s Orencia (abatacept), Amgen’s Aranesp (darbepoetin alfa) and Regeneron’s Eylea (aflibercept) looking “most likely.”

Cyltezo Label

Approval Letter


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