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Old 02-14-2018, 12:52 PM   #1
Lani
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Arrow biosimilar herceptin "progress"

HEALTH NEWSFEBRUARY 13, 2018 / 3:38 PM / A DAY AGO
Drug copies ready to take next bite out of Roche's cancer sales
Ben Hirschler

LONDON (Reuters) - European oncologists will soon get their hands on cut-price copies of breast cancer drug Herceptin, turning the screws on maker Roche and giving another boost to a new breed of companies focused on so-called biosimilars.

FILE PHOTO: The logo of Celltrion is seen at the company's headquarters in Incheon, South Korea, October 28, 2016. REUTERS/Kim Hong-Ji/File Photo
South Korea’s Celltrion is the biggest winner in the biosimilars boom, having tripled in value to $34 billion in the past year as it gears up for more product launches in Europe and the United States.

Biological drugs like Herceptin, a $7 billion-a-year seller, are complex molecules made in living cells. They have changed medicine in the past two decades and now offer rich pickings for firms making near-identical copies as patents expire.

Given the sky-high cost of many cancer drugs and growing political pressure over pricing, Ho-Ung Kim, head of strategy and operations at Celltrion Healthcare, believes the stars are aligning.

“The policies being discussed are more and more favorable for biosimilar companies,” he said during a visit to London.

Celltrion and a rival unit of Samsung aim to adapt the manufacturing skills that made South Korea a force in microchips and smartphones to making complex biotech drugs for international markets.

Today, Celltrion has two biosimilar drug factories in South Korea and plans a third, which Kim said might be located in Europe, after foreign business partners expressed concerns about the threat from North Korea.


Europe’s experience with biosimilars is being watched closely as a potential harbinger of disruption once biosimilar cancer drugs reach the U.S. market, the world’s biggest.

The speed at which copies of Roche’s Rituxan/MabThera for blood cancer - the first biosimilar of an antibody cancer drug - were adopted in Europe last year has surprised many experts.

Roche is certainly feeling the pain, with European sales of Rituxan down a bigger than expected 26 percent in the last quarter of 2017.

SAVING MONEY

FILE PHOTO: Flags bearing the South Korean national flag and Celltrion's flag flutter in the wind at the company's headquarters in Incheon, South Korea, October 28, 2016. REUTERS/Kim Hong-Ji /File Photo
Kim estimates that rapid Rituxan uptake means cash-strapped European healthcare systems are likely to save 1.2 billion euros ($1.5 billion) over five years - enough to make Europe’s health officials sit up an take notice.

Britain, Germany and the Nordic countries are all proactively looking at ways to increase of use of biosimilars, with Britain’s National Health Service aiming to save at least 200-300 million pounds ($280-420 million) a year by 2020-21.

At University College London Hospitals, doctors switched fully to the biosimilar version of Rituxan within just three months - far faster than the 18 months it took to reach 90 percent use with the first antibody biosimilar, a copy of Johnson & Johnson and Merck’s rheumatoid arthritis treatment Remicade.

In the case of Herceptin, biosimilars take-up may not be quite as rapid, since Roche has grabbed significant market share for a new under-the-skin injection form of the drug, which is more convenient than the original intravenous infusion.

But Roche is expecting four or five competitors to Herceptin in Europe in 2018, against only two copies of Rituxan.

As a result, Kim believes Herceptin biosimilars will see market uptake “in between” that of Rituxan and Remicade.

In Europe, Celltrion’s Herceptin copy is a few months behind a rival from Samsung Bioepis, a joint venture between Samsung Biologics and Biogen, which already has approval. Still, Celltrion could launch by April or May, in time for big hospital tenders in the second half of 2018.

Kim said U.S. Food and Drug Administration scrutiny of packaging issues at one of its plants would not derail plans.

Uptake of biosimilar versions of Rituxan, Herceptin and Avastin - another Roche drug soon losing protection - is less certain in the United States.

Although biosimilar companies believe there will eventually be significant U.S. demand, Baader Helvea analyst Bruno Bulic said relatively low penetration of Remicade copies suggested the United States might be a more resilient market for Roche’s mature drugs.

Still, consensus forecasts from analysts suggest sales of Roche’s three big drugs will halve over the next five years, leaving a gap Roche aims to fill with new drugs for cancer, multiple sclerosis and haemophilia.

Roche said biosimilar competition was a normal part of the drug life cycle and “biosimilars have a role to play in supporting the financial sustainability of healthcare systems”.

Editing by David Evans
Our Standards:The Thomson Reuters Trust Principles.
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Old 02-17-2018, 09:20 PM   #2
SoCalGal
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Re: biosimilar herceptin "progress"

It's all about the money. And not with particular concern for the consumer, aka, survivor.
__________________
1996 cancer WTF?! 1.3 cm lumpectomy Er/Pr neg. Her2+ (20nodes NEGATIVE) did CMF + rads. NED.
2002 recurrence. Bilateral mastectomy w/TFL autologous recon. Then ACx2. Skin lymphatic rash. Taxotere w/Herceptin x4. Herceptin/Xeloda. Finally stops spreading.
2003 - Back to surgery, remove skin mets, and will have surgery one week later when pathology can confirm margins.
‘03 latisimus dorsi flap to remove skin mets. CLEAN MARGINS. Continue single agent Herceptin thru 4/04. NED.
‘04 '05 & 06 tiny recurrences - scar line. surgery to cut out. NED each time.
1/2006 Rads again, to scar line. NED.

3/07 Heartbreaking news - mets! lungs.sternum. Try Tykerb/Xeloda. Tykerb/Carbo/Gemzar. Switch Oncs.
12/07 Herceptin.Tykerb. Markers go stable.
2/8/08 gamma knife 13mm stupid brain met.
3/08 Herceptin/tykerb/avastin/zometa.
3/09 brain NED. Lungs STABLE.
4/09 attack sternum (10 daysPHOTONS.5 days ELECTRONS)
9/09 MARKERS normal!
3/10 PET/CT=manubrium intensely metabolically active but stable. NEDhead.
Wash out 5/10 for tdm1 but 6/10 CT STABLE, PET improving. Markers normal. Brain NED. Resume just Herceptin plus ZOMETA
Dec 2010 Brain NED, lungs/sternum stable. markers normal.
MAR 2011 stop Herceptin/allergy! Go back on Tykerb and switch to Xgeva.
May-Aug 2011 Tykerb Herceptin Xgeva.
Sept 2011 Tykerb, Herceptin, Zometa, Avastin.
April 2012 sketchy drug trial in NYC. 6 weeks later I’m NED!
OCT 2012 PET/CT shows a bunch of freakin’ progression. Back to LA and Herceptin.avastin.zometa.
12/20/12 add in PERJETA!
March 2013 – 5 YEARS POST continue HAPZ
APRIL 2013 - 6 yrs stage 4. "FAILED" PETscan on 4/2/13
May 2013: rePetted - improvement in lungs, left adrenal stable, right 6th rib inactive, (must be PERJETA avastin) sternum and L1 fruckin'worsen. Drop zometa. ADD Xgeva. Doc says get rads consultant for L1 and possible biopsy of L1. I say, no thanks, doc. Lets see what xgeva brings to the table first. It's summer.
June-August 2013HAPX Herceptin Avastin Perjeta xgeva.
Sept - now - on chemo hold for calming tummy we hope. Markers stable for 2 months.
Nov 2013 - Herceptin-Perjeta-Avastin-Xgeva (collageneous colitis, which explains tummy probs, added Entocort)
December '13 BRAIN MRI ned in da head.
Jan 2014: CONTINUING on HAPX…
FEB 2014 PetCT clinical “impression”: 1. newbie nodule - SUV 1.5 right apical nodule, mildly hypermetabolic “suggestive” of worsening neoplastic lesion. 2. moderate worsening of the sternum – SUV 5.6 from 3.8
3. increasing sclerosis & decreasing activity of L1 met “suggests” mild healing. (SUV 9.4 v 12.1 in May ‘13)
4. scattered lung nodules, up to 5mm in size = stable, no increased activity
5. other small scattered sclerotic lesions, one in right iliac and one in thoracic vertebral body similar in appearance to L1 without PET activity and not clearly pathologic
APRIL 2014 - 6 YRS POST GAMMA ZAP, 7 YRS MBC & 18 YEARS FROM ORIGINAL DX!
October 2014: hold avastin, continue HPX
Feb 2015 Cancer you lost. NEDHEAD 7 years post gamma zap miracle, 8 years ST4, +19 yrs original diagnosis.
Continue HPX. Adding back Avastin
Nov 2015 pet/ct is mixed result. L1 SUV is worse. Continue Herceptin/avastin/xgeva. Might revisit Perjeta for L1. Meantime going for rads consult for L1
December 2015 - brain stable. Continue Herceptin, Perjeta, Avastin and xgeva.
Jan 2016: 5 days, 20 grays, Rads to L1 and continue on HAPX. I’m trying to "save" TDM1 for next line. Hope the rads work to quiet L1. Sciatic pain extraordinaire :((
Markers drop post rads.
2/24/16 HAP plus X - markers are down
SCIATIC PAIN DEAL BREAKER.
3/23/16 Laminectomy w/coflex implant L4/5. NO MORE SCIATIC PAIN!!! Healing.
APRIL 2016 - 9 YRS MBC
July 2016 - continue HAP plus Xgeva.
DEC 2016 - PETCT: mets to sternum, lungs, L1 still about the same in size and PET activity. Markers not bad. Not making changes if I don't need to. Herceptin/Perjeta/Avastin/Xgeva
APRIL 2017 10 YEARS MBC
December 2017 - Progression - gonna switch it up
FEB 2018 - Kadcyla 3 cycles ---->progression :(
MAY30th - bronchoscopy, w/foundation1 - her2 enriched
Aug 27, 2018 - start clinical trial ZW25
JAN 2019 - ZW25 seems to be keeping me stable
APRIL 2019 - ONE DOZEN YEARS LIVING METASTATIC
MAY 2019 - progression back on herceptin add xeloda
JUNE 2019 - "6 mos average survival" LMD & CNS new single brain met - one zap during 5 days true beam SBRT to cord met
10/30/19 - stable brain and cord. progression lungs and bones. washing out. applying for ds8201a w nivolumab. hope they take me.
12/27/19 - begin ds8401a w nivolumab. after 2nd cycle nodes melt away. after 3rd cycle chest scan shows Improvement, brain MRI shows improvement, resolved areas & nothing new. switch to plain ENHERTU. after 4th cycle, PETscan shows mostly resolved or improved results. Markers near normal. I'm stunned but grateful.
10/26/20 - June 2021 Tucatinib/xeloda/herceptin - stable ish.
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