GENERIC drug makers Teva Pharmaceutical Industries and Sandoz say they’re planning a major ramp-up in production of biosimilars — copies of high-priced medication used to deal with diseases corresponding to rheumatoid arthritis and most cancers — aiming to extend their share of an increasing market.
Greater than 55 brand-name blockbuster biologic medication, every with peak annual gross sales above $1 billion, are as a result of come off patent by the tip of the last decade, in response to business estimates.
Executives from Teva and Sandoz mentioned they’re concentrating on top-selling biologics corresponding to Humira, AbbVie, Inc.’s top-selling arthritis drug, which got here off-patent in Europe and is because of come off-patent in the US subsequent 12 months. However each firms face industrial and regulatory challenges, particularly in the US, the place biosimilars haven’t resulted in dramatically decrease costs for customers.
Biologics are advanced molecules cultivated inside residing cells, making it unimaginable to fabricate actual copies, as is the case with standard prescribed drugs created from chemical compounds.
Use of brand-name biologics usually account for an outsize proportion of drug spending in wealthier international locations.
One of the most important makers of generic medication, Israeli-based Teva mentioned it goals ultimately to safe a ten% international market share of biosimilars. The corporate has been grappling with a heavy debt load since a 2016 acquisition and lawsuits arising from the US opioid epidemic.
Teva at present has three accepted biosimilars and 13 in improvement.
“We are going full blast now,” Teva Chief Government Kåre Schultz mentioned in an interview with Reuters.
He mentioned the corporate was concentrating on “80% of what’s going off-patent in the next 10 years” together with large sellers just like the most cancers drug Keytruda.
A division of Novartis, Sandoz is at present the second largest participant after Pfizer, Inc. in the biosimilar market by product sales globally, per IQVIA information, cited by Sandoz. (Amgen is in third place).
Sandoz has launched eight biosimilar medication.
“We now have over 15 products in development, and in the next five years we would like to double the value of our marketed portfolio,” chief scientific officer Claire D’Abreu-Hayling advised Reuters, including that the biologics they intend to focus on are “really obvious opportunities”.
BLOCKBUSTERS COMING OFF PATENT
Novartis plans to spin off its Sandoz generics enterprise in 2023. The Swiss drugmaker mentioned the unit failed to draw a severe purchaser earlier this 12 months because it thought of choices for the unit’s future.
The greater than 55 blockbuster biologics coming off patent safety in the USA and Europe over the following decade account for greater than $270 billion in anticipated peak annual gross sales, in response to a McKinsey evaluation.
The evaluation projected the worth of the worldwide biosimilar market may greater than triple to an estimated $74 billion by 2030.
Subsequent 12 months may convey a take a look at case in the US market, with the anticipated launch of no less than six biosimilars for Humira, which brings in about $15 billion to $20 billion in annual gross sales and is accepted for autoimmune circumstances together with rheumatoid arthritis, psoriasis and Crohn’s illness.
Sandoz and Teva are each engaged on biosimilars for Humira.
However the crowded area raises a tricky query: Ought to the businesses goal the most important promoting biologics corresponding to Humira, or intention for smaller manufacturers that can seemingly appeal to fewer gamers, mentioned Barclays prescribed drugs analyst Emily Subject.
Teva goals to make sure it’s one of the primary three biosimilars in the marketplace for any given biologic, in response to Sven Dethlefs, govt VP, North America industrial. He mentioned the corporate meant to kick off a number of biosimilar improvement applications however would halt production if it couldn’t make the highest three.
Whereas going after Humira, Sandoz can also be concentrating on medication like Biogen’s a number of sclerosis drugs Tysabri, which is used in a a lot smaller affected person inhabitants. The corporate believes no different biosimilar is being actively developed for Tysabri, mentioned Chief Working Officer Pierre Bourdage.
A typical biosimilar prices $100 million to $300 million to develop and between six to 9 years to win approval, in response to McKinsey. About half of efforts launched throughout the US, European, and Japanese markets fail on the earliest levels, the report discovered.
Generics, which will be priced as a lot as 80% to 90% lower than branded capsules, barely price just a few million to develop.
Biosimilars are seen as “better than traditional generics, but nowhere near as good as branded pharma,” Emily Subject mentioned.
Industrial prospects may even rely on the regulatory surroundings. Whereas greater than 50 biosimilars have been launched into the European market, the USA has taken longer to arrange a regulatory pathway for biosimilars.
European regulators contemplate all accepted biosimilars on par with the unique biologic, which has helped increase uptake. Biosimilars have taken the bulk of market share from brand-name biologics in Europe and resulted in financial savings between 75% to 90% off the reference product costs, in response to a 2021 report by Duke College’s Margolis Middle for Well being Coverage.
In the USA, the Meals and Drug Administration (FDA) has accepted 39 biosimilars and 22 merchandise have been launched as of October, in response to an Amgen evaluation.
The FDA usually expects extra trial information earlier than designating a biosimilar as “interchangeable” with the unique biologic, which might enable it to be routinely changed with a biosimilar on the pharmacy counter.
In a observe final month, SVB Securities analysts predicted most US payers will seemingly follow branded Humira subsequent 12 months, however critically contemplate switching sufferers to interchangeable biosimilars by 2024.
Biosimilars launched in the US have solely taken about 20% of the quantity share of the biologics they’re primarily based on, in response to the Duke Report, with knockoffs delivering reductions of about 30% to 40%.
Patent-focused court docket battles have stymied some launches of biosimilars. Aggressive pricing methods from branded drug firms additionally helped neutralize the restricted reductions initially supplied by biosimilar makers. — Reuters