The U.S. Food and Drug Administration approved on Tuesday Amgen's (AMGN.O) Bkemv, the first biosimilar to AstraZeneca's (AZN.L), rare blood disorder treatment Soliris.
Amgen's drug will be marketed under the name Bkemv. Biosimilars are close copies of complex biological drugs.

Nearly five years after an FDA approval for Soliris in neuromyelitis optica spectrum disorder (NMOSD), AstraZeneca’s follow-on C5 drug Ultomiris has entered the rare neurological disease, as well.

Nearly seven years have passed since Alexion’s then-CEO and CFO stepped down amid an investigation into improper sales practices. Now, the rare disease specialist can put the episode completely in the rearview mirror thanks to a settlement with investors.

AstraZeneca has been successful at rolling out its long-acting complement C5 inhibitor Ultomiris in the uses approved for its predecessor Soliris – until now, that is.

Astrazeneca has the dominant complement inhibitor franchise via the acquisition of Alexion and its intravenous therapies Soliris and Ultomiris. But that position could soon come under fire from Novartis’s oral contender iptacopan.

Astra has oral projects of its own, although these are either way behind or focused on relatively small niches in paroxysmal nocturnal haemoglobinuria (PNH), their first indication. But Anita Hill, vice-president of global medical affairs at the Alexion division, believes that there is a good reason not to write off Soliris and Ultomiris just yet.

Roche is ready to wade into the increasingly ferocious fight for the paroxysmal nocturnal hemoglobinuria (PNH) space. The Big Pharma’s subcutaneous contender matched AstraZeneca’s intravenous blockbuster incumbent Soliris in phase 3, positioning it to file for regulatory approvals around the world.

For years, Alexion has been the only name in the game for a blood disease called paroxysmal nocturnal hemoglobinuria (PNH). Now, a number of Big Pharmas want in, vying to show their candidates can go head-to-head with the AstraZeneca unit's market-leading therapies Ultomiris and Soliris.

Roche’s attempt to muscle in on paroxysmal nocturnal hemoglobinuria (PNH) is on track. The subcutaneous anti-C5 recycling antibody crovalimab improved outcomes in a Chinese phase 3 trial, giving the Big Pharma a boost as it closes in on data from its showdown with AstraZeneca’s Soliris.

Novartis is coming for the jewels of AstraZeneca’s $39 billion takeover of Alexion. In a phase 3 trial, the Swiss drugmaker’s iptacopan beat the incumbent rare disease drugs Soliris and Ultomiris, advancing its plan (PDF) to turn the oral challenger into a $3 billion-a-year blockbuster.

• The biotech giant shared encouraging results for its Soliris biosimilar.
• The drug candidate could haul in $300 million in annual sales for Amgen.
• The stock appears be a buy for dividend growth investors.