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Amgen Humira Biosimilar Briefing Documents Look Good
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Briefing documents issued by the FDA ahead of an advisory panel meeting for Amgen Inc.’s (AMGN - Free Report) ABP 501, a biosimilar version of AbbVie Inc.’s (ABBV - Free Report) Humira, look good.
Amgen is seeking FDA approval for ABP 501 for indications for which Humira is approved including rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), psoriatic arthritis (PsA), ankylosing spondylitis(AS), adult Crohn’s disease (CD), ulcerative colitis (UC), plaque psoriasis (PsO) – all in specific patient populations.
According to the briefing documents, the data on ABP 501 shows that it is highly similar to Humira in RA and PsO. The documents also note that the evidence indicates that the extrapolation of biosimilarity to the indications for which Amgen is seeking approval (JIA, PsA, AS, adult CD, and UC), is scientifically justified.
Overall, the documents look favorable and the approval of ABP 501 would be a huge boost for Amgen which itself is facing biosimilar threats for quite a few of its key drugs. U.S. sales of Humira were about $8.4 billion in 2015. Of course, with Humira being its flagship product and a major contributor to the top line, AbbVie will leave no stone unturned to delay the entry of direct biosimilar competition.
While Humira’s composition of matter patent in the U.S. is expected to expire in Dec 2016, AbbVie has several non-composition of matter patents covering Humira in the U.S. with none of these expected to expire before 2022.
The FDA’s arthritis advisory panel will be meeting tomorrow to review ABP 501. While the FDA is not required to do so, it usually follows the advice of its panel. The agency is expected to respond on the approval status of ABP 501 by Sep 25, 2016.
Meanwhile, the arthritis advisory panel will be meeting on Jul 13 to review a biosimilar version (Sandoz’s GP2015), of Amgen’s blockbuster drug, Enbrel.
Both Amgen and AbbVie are Zacks Rank #3 (Hold) stocks. A couple of better-ranked stocks in the health care sector are Fibrocell Science, Inc. and Innoviva, Inc. (INVA - Free Report) – both are Zacks Rank #1 (Strong Buy) stocks.
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Amgen Humira Biosimilar Briefing Documents Look Good
Briefing documents issued by the FDA ahead of an advisory panel meeting for Amgen Inc.’s (AMGN - Free Report) ABP 501, a biosimilar version of AbbVie Inc.’s (ABBV - Free Report) Humira, look good.
Amgen is seeking FDA approval for ABP 501 for indications for which Humira is approved including rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), psoriatic arthritis (PsA), ankylosing spondylitis(AS), adult Crohn’s disease (CD), ulcerative colitis (UC), plaque psoriasis (PsO) – all in specific patient populations.
According to the briefing documents, the data on ABP 501 shows that it is highly similar to Humira in RA and PsO. The documents also note that the evidence indicates that the extrapolation of biosimilarity to the indications for which Amgen is seeking approval (JIA, PsA, AS, adult CD, and UC), is scientifically justified.
Overall, the documents look favorable and the approval of ABP 501 would be a huge boost for Amgen which itself is facing biosimilar threats for quite a few of its key drugs. U.S. sales of Humira were about $8.4 billion in 2015. Of course, with Humira being its flagship product and a major contributor to the top line, AbbVie will leave no stone unturned to delay the entry of direct biosimilar competition.
While Humira’s composition of matter patent in the U.S. is expected to expire in Dec 2016, AbbVie has several non-composition of matter patents covering Humira in the U.S. with none of these expected to expire before 2022.
The FDA’s arthritis advisory panel will be meeting tomorrow to review ABP 501. While the FDA is not required to do so, it usually follows the advice of its panel. The agency is expected to respond on the approval status of ABP 501 by Sep 25, 2016.
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Meanwhile, the arthritis advisory panel will be meeting on Jul 13 to review a biosimilar version (Sandoz’s GP2015), of Amgen’s blockbuster drug, Enbrel.
Both Amgen and AbbVie are Zacks Rank #3 (Hold) stocks. A couple of better-ranked stocks in the health care sector are Fibrocell Science, Inc. and Innoviva, Inc. (INVA - Free Report) – both are Zacks Rank #1 (Strong Buy) stocks.
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report >>