2. Neulasta

Neulasta faces the potential of biosim competition from Mylan this year. (Image: Amgen)

Neulasta 
Company: Amgen 
2017 U.S. sales: $3.93 billion 
Use: White blood cell booster 
Competition expected: Mid-2018 

After a 2015 patent expiration, Amgen stalwart Neulasta could finally face its first biosim competition this year. At January's J.P. Morgan Healthcare Conference in San Francisco, Mylan president Rajiv Malik said his company could have a mid-2018 opportunity to launch its biosimilar. 

First approved in 2002, Neulasta is used to help patients boost their white blood cell count after treatment with chemotherapies. The Amgen blockbuster pulled in $3.93 billion in the U.S. last year, enough to rank second in the list of top meds susceptible to competition this year.

Mylan's effort already hit a speed bump after an FDA complete response letter in October, but that has been answered, Malik said at the JPM conference in January. Further, a company spokesperson told Regulatory Focus the drugmaker expects to win biosim approval this year. 

Also seeking a biosim nod is Sandoz, which received its own complete response letter and plans to refile in 2019, according to the company's online pipeline. Coherus, Pfenex and Pfizer are also working on copycats, according to analysts with Mizuho. In January, the group wrote that they expect Neulasta will face biosim competition in mid-2018.

Coherus said in its fourth-quarter results press release that it expects to launch its biosim in the U.S. in the second half of this year, "dependent on regulatory review and approval timing." Last week, a judge tossed a patent case brought by Amgen against the biosim developer.

Drug manager and analytics company Optum believes biosims could enter in the fourth quarter of 2018 or later. 

RELATED: Mylan and Biocon biosimilar of Amgen’s Neulasta hit with manufacturing-related CRL 

In Amgen's 10-K filing with the SEC, the company reported that its "final material patent" for the drug expired in 2015. The company noted the possibility of biosim approvals this year. 

On Amgen's fourth-quarter conference call, CFO David Meline said the company embraces expected competitive challenges this year, including to Neulasta, Aranesp and Sensipar.

Meanwhile, the big biotech is facing off against Sandoz in a legal case over Enbrel that will determine a biosim launch timeline for that blockbuster; Epogen also faces a 2018 biosim threat. All of comes this while its PCSK9 for high cholesterol, Repatha, will likely face new pressure from Sanofi and Regeneron's Praluent. The latter drug recently demonstrated the ability to cut death risks, and the partners lowered their price in a push to grab market share.

2. Neulasta