FDA approves lower-cost alternative to biotech drug Humira

The Food and Drug Administration has approved Amgen's Amjevita (adalimumab-atto), a biosimilar of AbbVie's Amgen (adalimumab) and the fourth US biosimilar, the company announced Friday.

Amjevita becomes the fourth biosimilar to be approved in the United States, following Sandoz' Zarxio (filgrastim), Pfizer's Inflectra (infliximab) and Erelzi (etanercept), a second for Sandoz.

According to a report in Medscape News by Troy Brown, "The biosimilar is approved for the treatment of adults with moderately to severely active rheumatoid arthritis, active psoriatic arthritis, active ankylosing spondylitis, moderately to severely active Crohn's disease, moderately to severely active ulcerative colitis, and moderate-to-severe plaque psoriasis".

The FDA's approval of Amjevita is based on review of evidence that included structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data and other clinical safety and effectiveness data that demonstrates Amjevita is biosimilar to Humira. Its most serious side effects include infection, cancerous conditions and injection-site reactions.

Nigel Farage: I did not bare all in late-night swim
Thanking campaigners and activists for their work in securing a Brexit win, he said: 'And now, folks, I want my life back'. It polled the third highest number of votes in the 2015 general election after the Conservative and Labour parties.

However, the company may not be able to launch its drug until 2022, because AbbVie is claiming that Amjevita infringes patent protection on Humira that is valid until 2022.

Biosimilars, like Amjevita, are designed as lower cost treatments and similar to generics but are made with living organisms and aren't identical to the complex compounds they replicate. In July, an FDA panel recommended the drug for approval - so marketing approval was seen as a formality.

Amjevita may not hit pharmacies immediately, though. The company did not disclose its plans to launch the drug or the prices it intends to put up in the Friday released issue. The company has sought to stave off Novartis' efforts to steal some of its market share, although the Swiss pharma has already won approval for a biosimilar copy of Amgen's Neupogen and Enbrel.

First approved in 2002, Humira accounted for 60 percent of AbbVie's total revenue a year ago. Humira sales are anticipated to fall in the coming years. Drugs treating breast cancer and colorectal cancer are now in Phase 3 trials.

  • Protests expected around Charlotte Panthers game

    Protests expected around Charlotte Panthers game

    After days of protest, Charlotte police finally released their footage of Keith Lamont Scott being shot and killed. Scott had in his possession, officers chose to take enforcement action for public safety concerns", police said.

    Canada beats Russia 5-3, advances to World Cup finals

    There was a fleeting moment in the second period that maybe this time would be different for Ovechkin and Russian Federation . When you're able to lead at this level of a group of leaders and you're able to take control, it shows how special he is.

    Jose Mourinho: 'Wayne Rooney affected by England criticism'

    He admitted that he form of his captain Wayne Rooney - who has described criticism of himself as " rubbish " - had been patchy. We like to say a very good start to the season was better than we could expect, we were guilty to raise expectations of people.
  • Iran releases Canadian-Iranian professor held since June

    Iran releases Canadian-Iranian professor held since June

    A foreign ministry spokesman, quoted by the official IRNA news agency, said Homa Hoodfar was released on humanitarian grounds. In July, Iran announced indictments for Mrs Hoodfar and three others, without providing any details about the accusations.
    Forces kill Houthi general on Saudi-Yemen border

    Forces kill Houthi general on Saudi-Yemen border

    The United Nations secretary general, Ban Ki-moon, condemned the attack, which killed at least 26 civilians, according to human rights monitors.
    Hamdog creater Mark Murray patents a cross between hamburger and hotdog

    Hamdog creater Mark Murray patents a cross between hamburger and hotdog

    After patenting his unusual bun, he began selling his nifty combination at different fairs and markets around Western Australia. Currently, Murray is looking for people to help him spread the Hamdog love by investing in a franchise for just $10,000.
  • Former Clinton foe offers debate advice to Donald Trump

    Former Clinton foe offers debate advice to Donald Trump

    But it will not be easy for her to wipe away, in a 90-minute debate, an image forged in public opinion over a quarter-century. During her first run for the presidency, in 2008, Clinton presented herself as a tough, Thatcher-style "iron lady".
    Garnett says 'farewell' after 21 NBA seasons

    Garnett says 'farewell' after 21 NBA seasons

    He was traded from the team in 2007 to the Boston Celtics, where he won his only National Basketball Association championship. But don't forget he also won an Olympic gold medal in 2000, averaging 10.8 points, 9.1 rebounds and 2.1 assists.
    Is there a better game planner than Bill Belichick

    Is there a better game planner than Bill Belichick

    On the Mike and Mike Show on ESPN Thursday they asked if the Patriots and Texans game was an AFC championship game preview. Jamie Collins , Patriots - New England's defense in its entirety could get a star.
  • Bears Sign Matt Barkley From Practice Squad

    Both teams struggled with injuries to key players throughout the season and both teams also finished last in their division. It was his first action as a Bear since the preseason finale, and he said he can benefit from that time .
    Santner, Boult lead Kiwis fightback against India

    Santner, Boult lead Kiwis fightback against India

    But Rohit Sharma and R Ashwin shared a decent stand of 52 before Sharma was out for 35, lobbing Santner to Ish Sodhi at mid-on. Left-armer Neil Wagner pitched all his deliveries short to him, the third of which - from around the wicket - drew a top edge.

    Prescott Solid but Not Spectacular in Debut

    Prescott is confident the chemistry with Bryant will come. "So you have to handle those kinds of situations when they come up". However, the most important catch of the game for the Giants was what they were waiting 700 days for.