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The first biosimilar has finally arrived in the U.S. with Novartis’ generic arm, Sandoz, launching its biosimilar version of Amgen’s (AMGN - Free Report) Neupogen. With Zarxio being the first biosimilar to launch in the U.S. market, investor focus will remain on its impact on Neupogen sales in the coming quarters. Meanwhile, Tetraphase (TTPH - Free Report) suffered a huge setback with the company announcing disappointing late-stage data on its lead pipeline candidate.

Recap of the Week’s Most Important Stories

1. Zarxio, the first FDA-approved biosimilar, was launched last week by Sandoz. Approved earlier this year in March, Zarxio is the biosimilar version of Amgen’s blockbuster drug, Neupogen (filgrastim). While biosimilars have been available in the EU for quite a while, there was no regulatory pathway for biosimilars in the U.S.

However, this changed with the passing of The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) as part of the Affordable Care Act that President Obama signed into law in Mar 2010. Biosimilars are expected to reduce healthcare costs and provide a large number of patients with access to much needed biologic treatments.

Meanwhile, Amgen continues to progress with its pipeline. The company, which recently gained FDA approval for its PCSK9 inhibitor, Repatha, filed a regulatory application in the EU last week for etelcalcetide. The company is looking to get etelcalcetide approved for the treatment of secondary hyperparathyroidism in adult patients with chronic kidney disease on hemodialysis therapy.

2. Tetraphase suffered a huge setback with its experimental antibiotic, eravacycline, failing to achieve the primary endpoint in a late stage study. Eravacycline failed to show statistical non-inferiority compared to levofloxacin in the study being conducted for the treatment of complicated urinary tract infections (cUTI). Shares were down significantly in pre-market trading.

3. Geron’s (GERN - Free Report) shares were up about 13% on data from two separate studies suggesting disease-modifying activity for the company’s sole pipeline candidate, imetelstat, which is being evaluated for hematologic myeloid malignancies. This is encouraging news for Geron, which has had its share of hiccups related to the development of imetelstat. However, things started looking up for the company last year in November when it struck a deal with Johnson & Johnson’s Janssen Biotech for the development and commercialization of imetelstat.

4. Alexion (ALXN - Free Report) , which gained EU approval recently for its ultra-rare metabolic disorder drug, Kanuma, is facing a delay in the U.S. The company said that the FDA has extended the PDUFA date for Kanuma by three months which means a response from the agency should now be out by Dec 8. Importantly, the FDA has not asked for additional clinical data (Read more: Alexion's Kanuma FDA Action Date Delayed by Three Months).

5. ACADIA (ACAD - Free Report) submitted a NDA seeking approval for its lead pipeline candidate, Nuplazid (pimavanserin). The company is looking to get Nuplazid approved for the treatment of psychosis associated with Parkinson’s disease. Timely approval could very well make Nuplazid the first treatment to be approved for this indication. Of the one million people suffering from Parkinson’s in the U.S., about 40% are estimated to suffer from Parkinson’s disease psychosis, which is characterized by hallucinations and delusions. ACADIA is seeking priority review for its treatment, which has breakthrough therapy status.


Over the last four trading days, Regeneron (REGN - Free Report) was the highest gainer (9.33%) among major biotechs. Meanwhile, Biogen (BIIB - Free Report) lost 26.1% over the last six months with Regeneron being the highest gainer (28.6%) during this period as well.

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The NASDAQ Biotechnology Index was up 5.6% over the last four trading days (See the last biotech stock roundup here: Biotech Stock Roundup: Amgen in the News, ARIAD a Takeover Target?).

What's Next in the Biotech World?

Watch out for the usual pipeline and regulatory updates from biotech companies this week.

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