Key recent events from the European and US biosimilars market
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Insulin generics hit the US, but what about biosimilars?
Drug prices around the world, in particular
in the US, continue to capture the headlines. And significant price differences
between developed markets, like the US and UK, are inflaming an already
delicate situation.[1]
In specific classes of drugs like insulin,
prices in the US doubled between 2012 and 2016, according to an analysis shared
with Reuters, even in older segments of the market.[2]
And this is a class of medication that is absolutely essential to patient
health. Going without is not an option.
This hasn’t gone unnoticed by certain
members of the US Senate. In February 2019, the heads of the influential Senate
Finance Committee launched an investigation into the high price of insulin,
demanding answers from Lilly, Sanofi and Novo Nordisk – the three manufacturers
that control most of the global market for insulin.[3]
The Senate Finance Committee’s ‘shot across
the bow’ of Lilly, Sanofi and Novo Nordisk seems to have stirred one company
into action. This week Lilly announced that it would be selling an authorised
generic version of Humalog (insulin lispro), in what the New York Times has
said is “an effort to head off criticism about the rising costs of prescription
drugs.”[4]
The generic version, to be called Insulin Lispro, will be sold at a 50 percent
discount to the list price of Humalog.
In Europe biosimilar competition within the
insulin market started in September 2014 when Lilly’s Abasaglar, a biosimilar
version of Lantus (insulin glargine), was approved.[5]
Since then three other insulin biosimilars have been approved, including
Semglee (insulin glargine; Mylan/Biocon),[6]
Lusduna (insulin glargine; Merck Sharp & Dohme)[7]
and Insulin Lispro Sanofi.[8]
Lusduna has since been removed from the European market.
Due to the regulatory differences between
the US and Europe, insulin biosimilars won’t be available in the US until March
2020. This is when the US FDA begins transitioning approved marketing
applications for insulin, and a number of other medicines, which were
previously approved as drugs under section 505 of the FD&C Act, to be biologics.
Concerns, however, have been raised by a
number of US senators that the current framework for this transition will “briefly
halt companies from seeking to bring insulin competition to market.”[9] Senators
Dick Durbin (D-IL), Kevin Cramer (R-ND), Tina Smith (D-MN) and Bill Cassidy
(R-LA) wrote in a letter to FDA Commissioner Scott Gottlieb that although current
FDA guidance will facilitate the submission of biosimilar insulin products for
the first time, “the current regulatory framework still introduces perverse
incentives that could delay the introduction of low-cost insulin products into
the market in the short-term, when they are needed most.”[10]
Competition in the US insulin market is
desperately needed in order to avoid potentially deadly “insulin rationing.”[11]
The move by Lilly is perhaps a sign of things to come, with Sanofi and Novo
Nordisk potentially considering similar moves.
Pegfilgrastim biosimilars launch in the UK and Canada, but can Amgen protect Neulasta revenues?
Within a few days of each other, Napp
Pharmaceuticals and Apobiologix announced the launch of their respective long-acting
pegfilgrastim biosimilars, Pelmeg[12]
and Lapelga,[13]
in the UK and Canada. This follows Pelmeg’s approval by the European Commission
(EC) in November 2018,[14]
and Lapelga’s approval by Health Canada in June 2018.[15]
Biosimilar competition in the short-acting
filgrastim segment of the market is well-established, with the first filgrastim
biosimilars approved in Europe in September 2009. Filgrastim biosimilars took
longer to be approved in Canada, with the first approval being seen in 2015.[16]
Since their approval and launch in Europe,
filgrastim biosimilars have captured 100 percent of the accessible market in
certain European countries, such as Slovakia, Romania and Hungary.[17] Indeed,
the European average market share for filgrastim biosimilars, at the end of
2017, was just over 90 percent. Uptake rates in Canada have been far slower.[18]
One would expect similar uptake rates for
pegfilgrastim biosimilars in Europe. In its press release, Napp Pharmaceuticals
comments that “longer-acting alternatives can offer a less demanding treatment
schedule for patients between chemotherapy cycles than the current standard of
care, which requires daily injections.”
The only difference between the
short-acting and long-acting filgrastim markets is what Amgen has done in order
to defend Neulasta, the branded version of pegfilgrastim, from biosimilar
competition. In the US Neulasta’s on-body delivery device, OnPro, has captured
over 60 percent of the pegfilgrastim market. Following a recommendation for
approval in Europe in February 2018, Amgen are hoping that the strategy
employed in the US will also work in Europe.[19]
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New dosage form for trastuzumab biosimilar approved in Europe, as FDA approves Roche’s Herceptin Hylecta, its subcutaneous formulation of Herceptin
Hot on the heels of its US FDA approval for
the company’s trastuzumab biosimilar, Ontruzant, in January 2019,[20]
Samsung Bioepis has announced that the European Medicines Agency (EMA) has
approved a 420mg pack size. This follows the the European launch of the 150mg pack
size in March 2018.[21]
This enables Samsung Bioepis, via its
commercial partner in Europe, MSD, to compete more aggressively against Roche.
Moreover, MSD will also be able to offer the same pack sizes as Kanjinti,
Amgen’s trastuzumab biosimilar which was approved in Europe in May 2018.[22]
Since the first European launch in March
2018, trastuzumab biosimilars have captured a decent share of the accessible
market. Roche’s biosimilar defense strategy for Herceptin has focused on a
range of tactics, including the development of a subcutaneous version of
Herceptin. Roche has developed this in collaboration with Halozyme, and it was
approved in Europe in September 2013.[23]
Where available in Europe, it represented as much as half the market in volume
terms toward the end of 2017.[24]
More recently the subcutaneous formulation
of Herceptin, Herceptin Hylecta was approved in the US. Herceptin Hylecta
contains the same monoclonal antibody (mAb) as IV trastuzumab in combination
with recombinant human hyaluronidase PH20, an enzyme used to deliver
trastuzumab subcutaneously using Halozyme’s Enhanze drug delivery technology.
Whereas IV trastuzumab takes 30-90 minutes to administer, this ready-to-use
formulation can be administered to 2-5 minutes.
With biosimilar
companies unable to challenge the greater convenience of subcutaneous
Herceptin, due to them only being able to offer IV administered biosimilars,
the approval of Herceptin Hylecta in the US could enable Roche to protect
Herceptin revenues in the US in the face of impending biosimilar competition,
which is expected in 2019.
Whether you’re a seasoned
biosimilars professional, or just starting out on your biosimilars journey,
it’s important to keep up to date with what’s happening in the biosimilars
market. With commercialisation of biosimilars now moving front and centre of the
debate, Pharma IQ’s Biosimilars Commercialisation Summit (Amsterdam; May 14-16,
2019) will provide a timely forum to debate some of the most critical, market
shaping issues. It’s the only biosimilars conference dedicated to the commercialisation
of biosimilars. Click here to learn more.
[1] How the U.S. Pays 3 Times More for Drugs (accessed March 2019).
Retrieved from https://www.scientificamerican.com/article/how-the-u-s-pays-3-times-more-for-drugs/
[2] U.S. insulin costs per patient nearly doubled from 2012 to 2016:
study (January 2019). Retrieved from https://uk.reuters.com/article/us-usa-healthcare-diabetes-cost/u-s-insulin-costs-per-patient-nearly-doubled-from-2012-to-2016-study-idUKKCN1PG136
[3] Powerful Senate committee launches bipartisan probe into insulin
pricing (February 2019). Retrieved from https://www.statnews.com/2019/02/22/powerful-senate-committee-launches-bipartisan-probe-into-insulin-pricing/
[4] Eli Lilly Will Sell Half-Price Version of Humalog, Its Popular
Insulin (March 2019). Retrieved from https://www.nytimes.com/2019/03/04/health/insulin-price-humalog-generic.html
[5] EPAR: Abasaglar (insulin glargine) (accessed March 2019). Retrieved
from https://www.ema.europa.eu/en/medicines/human/EPAR/abasaglar-previously-abasria
[6] EPAR: Semglee (insulin glargine) (accessed March 2019). Retrieved
from https://www.ema.europa.eu/en/medicines/human/EPAR/semglee
[7] EPAR: Lusduna (insulin glargine) (accessed March 2019). Retrieved
from https://www.ema.europa.eu/en/medicines/human/EPAR/lusduna
[8] EPAR: Insulin Lispro Sanofi (insulin lispro) (accessed March 2019).
Retrieved from https://www.ema.europa.eu/en/medicines/human/EPAR/insulin-lispro-sanofi
[9] Senators Seek Changes to FDA Guidance to Speed Entry of Insulin
Biosimilars (March 2019). Retrieved from https://www.raps.org/news-and-articles/news-articles/2019/3/senators-seek-changes-to-fda-guidance-to-speed-ent
[10] Letter to FDA Commissioner Scott Gottlieb (March 2019). Retrieved
from https://www.durbin.senate.gov/imo/media/doc/Senate%20Letter%20to%20FDA%20on%20Insulin.pdf
[11] Eli Lilly seeks to quell drug price anger with cheaper insulin
(March 2019). Retrieved from https://uk.reuters.com/article/us-lilly-insulin/eli-lilly-seeks-to-quell-drug-price-anger-with-cheaper-insulin-idUKKCN1QL12G
[12] Napp launches Pelmeg (biosimilar pegfilgrastim) in the UK (March
2019). Retrieved from http://napp.co.uk/archives/secondary_news/napp-launches-pelmeg%E2%96%BCbiosimilar-pegfilgrastim-uk
[13] Apobiologix Launches Pegfilgrastim Biosimilar in Canada (March
2019). Retrieved from https://www.centerforbiosimilars.com/news/apobiologix-launches-pegfilgrastim-biosimilar-in-canada
[14] EPAR: Pelmeg (pegfilgrastim) (accessed March 2019). Retrieved from https://www.ema.europa.eu/en/medicines/human/EPAR/pelmeg
[15] Apobiologix's Biosimilar Pegfilgrastim Approved in Canada (June
2018). Retrieved from http://www1.apotex.com/global/about-us/press-center/2018/06/01/apotex-builds-momentum-in-canadas-biosimilar-market-after-worlds-first-approval
[16] The Biosimilar Landscape in Canada (August 2018). Retrieved from https://www.bereskinparr.com/doc/pdf/the-biosimilar-landscape-in-canada
[17] The impact of biosimilar competition in Europe (September 2018).
Retrieved from https://ec.europa.eu/docsroom/documents/31642/attachments/1/translations/en/renditions/native
[18] Potential savings from biosimilars in Canada (April 2017).
Retrieved from https://www.cadth.ca/sites/default/files/symp-2017/presentations/april24-2017/Concurrent-Session-B4-Gary-Warwick.pdf
[19] Biosimilar buffer? EU thumbs up for Amgen’s Neulasta delivery
device (March 2018). Retrieved from https://www.biopharma-reporter.com/Article/2018/03/06/Biosimilar-buffer-EU-thumbs-up-for-Amgen-s-Neulasta-delivery-device
[20] US FDA Approves ONTRUZANT (trastuzumab-dttb), Samsung Bioepis’ First
Oncology Medicine in the United States (January 2019). Retrieved from http://samsungbioepis.com/en/newsroom/detail/Samsung-Bioepis-First-Oncology-Medicine.html
[21] Samsung Bioepis gains approval to sell bigger-size Ontruzant in
Europe (March 2019). Retrieved from http://www.koreaherald.com/view.php?ud=20190305000460
[22] EPAR: Kanjinti (trastuzumab) (accessed March 2019). Retrieved from https://www.ema.europa.eu/en/medicines/human/EPAR/kanjinti
[23] Roche wins EU approval for injectable Herceptin (September 2013). Retrieved
from http://www.pmlive.com/pharma_news/roche_wins_eu_approval_for_injectable_herceptin_500572
[24] US nod nears for first Herceptin biosimilar as the European fight
begins (November 2017). Retrieved from http://www.evaluate.com/vantage/articles/news/policy-and-regulation/us-nod-nears-first-herceptin-biosimilar-european-fight