We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Pfizer to Launch Remicade Biosimilar in U.S. in November
Read MoreHide Full Article
Pfizer Inc. (PFE - Free Report) announced that its Inflectra injection, a biosimilar version of Johnson & Johnson’s (JNJ - Free Report) blockbuster drug Remicade, will be available in the U.S. in late November.
Inflectra is the first and only biosimilar monoclonal antibody (mAb) therapy and only the second biosimilar to be launched in the U.S. Pfizer plans to start shipments to wholesalers at a 15% discount to Remicade’s present wholesale prices.
Inflectra is approved for use across all eligible indications of the reference product, Remicade, which include reducing signs and symptoms in patients with rheumatoid arthritis, adult ulcerative colitis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and adult and pediatric Crohn’s disease.
Remicade scooped up sales of $2.9 billion (including U.S. exports) in the U.S. in the first six months of 2016 and $4.5 billion (U.S.) in 2015.
We remind investors that Celltrion’s biosimilar version of Remicade, Inflectra, had gained FDA approval in April. Pfizer has exclusive commercialization rights to Inflectra in the U.S. and certain other territories. Inflectra is already available in Europe and many other markets outside the U.S.
In August, the District of Massachusetts Federal Court ruled in favor of Celltrion and Hospira in an ongoing patent dispute with J&J and said that U.S. Patent No. 6,284,471 for Remicade ('471 patent) is invalid. J&J then said it intends to appeal the decision (Read: J&J Remicade Patent Invalid, Pfizer to Launch Inflectra?).
Pfizer’s launch would be before a resolution to the dispute.
Pfizer’s Sep 2015 Hospira acquisition expanded its portfolio of biosimilars. Notably, biosimilars of Herceptin, Rituxan/MabThera, Avastin and Humira are in phase III development while biosimilars of Neupogen and Neulasta are in phase I. Pfizer believes that the market for biosimilars is huge and can grow to $17–$20 billion by 2020.In the second quarter of 2016, Pfizer recorded biosimilars revenues of $78 million.
In fact, the pharmaceutical industry is set for the approaching wave of biosimilars, which are essentially generic versions of expensive biologic drugs.
Several pharma as well as biotech companies are involved in the development of biosimilars. The first biosimilar to gain approval in the U.S. was Sandoz’s (Novartis AG’s (NVS - Free Report) generic arm) Zarxio, a biosimilar version of Amgen Inc.’s (AMGN - Free Report) Neupogen. Zarxio was launched in the U.S. in Sep 2015.
Other approved biosimilars include Sandoz’s Erelzi, a biosimilar to Amgen’s Enbrel (etanercept) and Amgen’s Amjevita, a biosimilar version of Abbvie’s Humira.
Several other companies like Merck, Biogen and Allergan are also targeting the highly lucrative biosimilars’ market.
Beyond this Analyst Blog, would you like to see Zacks' best recommendations that are not available to the public? Our Executive VP, Steve Reitmeister, knows when key trades are about to be triggered and which of our experts has the hottest hand. Click to see them now>>
Unique Zacks Analysis of Your Chosen Ticker
Pick one free report - opportunity may be withdrawn at any time
Image: Bigstock
Pfizer to Launch Remicade Biosimilar in U.S. in November
Pfizer Inc. (PFE - Free Report) announced that its Inflectra injection, a biosimilar version of Johnson & Johnson’s (JNJ - Free Report) blockbuster drug Remicade, will be available in the U.S. in late November.
Inflectra is the first and only biosimilar monoclonal antibody (mAb) therapy and only the second biosimilar to be launched in the U.S. Pfizer plans to start shipments to wholesalers at a 15% discount to Remicade’s present wholesale prices.
Inflectra is approved for use across all eligible indications of the reference product, Remicade, which include reducing signs and symptoms in patients with rheumatoid arthritis, adult ulcerative colitis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and adult and pediatric Crohn’s disease.
Remicade scooped up sales of $2.9 billion (including U.S. exports) in the U.S. in the first six months of 2016 and $4.5 billion (U.S.) in 2015.
PFIZER INC Price
PFIZER INC Price | PFIZER INC Quote
We remind investors that Celltrion’s biosimilar version of Remicade, Inflectra, had gained FDA approval in April. Pfizer has exclusive commercialization rights to Inflectra in the U.S. and certain other territories. Inflectra is already available in Europe and many other markets outside the U.S.
In August, the District of Massachusetts Federal Court ruled in favor of Celltrion and Hospira in an ongoing patent dispute with J&J and said that U.S. Patent No. 6,284,471 for Remicade ('471 patent) is invalid. J&J then said it intends to appeal the decision (Read: J&J Remicade Patent Invalid, Pfizer to Launch Inflectra?).
Pfizer’s launch would be before a resolution to the dispute.
Pfizer’s Sep 2015 Hospira acquisition expanded its portfolio of biosimilars. Notably, biosimilars of Herceptin, Rituxan/MabThera, Avastin and Humira are in phase III development while biosimilars of Neupogen and Neulasta are in phase I. Pfizer believes that the market for biosimilars is huge and can grow to $17–$20 billion by 2020.In the second quarter of 2016, Pfizer recorded biosimilars revenues of $78 million.
In fact, the pharmaceutical industry is set for the approaching wave of biosimilars, which are essentially generic versions of expensive biologic drugs.
Several pharma as well as biotech companies are involved in the development of biosimilars. The first biosimilar to gain approval in the U.S. was Sandoz’s (Novartis AG’s (NVS - Free Report) generic arm) Zarxio, a biosimilar version of Amgen Inc.’s (AMGN - Free Report) Neupogen. Zarxio was launched in the U.S. in Sep 2015.
Other approved biosimilars include Sandoz’s Erelzi, a biosimilar to Amgen’s Enbrel (etanercept) and Amgen’s Amjevita, a biosimilar version of Abbvie’s Humira.
Several other companies like Merck, Biogen and Allergan are also targeting the highly lucrative biosimilars’ market.
J&J and Pfizer are both Zacks Rank #3 (Hold) stocks. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Confidential from Zacks
Beyond this Analyst Blog, would you like to see Zacks' best recommendations that are not available to the public? Our Executive VP, Steve Reitmeister, knows when key trades are about to be triggered and which of our experts has the hottest hand. Click to see them now>>