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Generic drugs by the numbers & key market company’s generics business, large of $8.7-bn, which represented 55% of downsized, or divested certain manu-
debt caused by its $40.5-bn acquisi-
the company’s 2023 overall revenues facturing facilities globally that were
developments tion of Allergan’s generics business in of $15.8-bn. In North America, the deemed to be no longer viable either
2016, and declining revenue from its company reported 2023 revenues in due to surplus capacity, challenging
eneric-drug approvals in the approved or tentatively approved 956 PATRICIA VAN ARNUM number one specialty innovator pro- its generics business of $3.475-bn (a market dynamics, or a shift in its pro-
US reached a recent high in generic-drug applications, i.e., abbre- Editorial Director duct at the time, Copaxone (glatiramer 2% decline year-over-year), $3.664-bn duct portfolio toward more complex
G2023 although the number viated new drug applications (ANDAs) Drug, Chemical & Associated acetate) for treating multiple sclerosis, in Europe (a 6% gain year-over-year), products.
of fi rst-generic approvals were down (see Figure 1). For defi nition, a tentative Technologies Association,Inc. (DCAT) which faced its own generic-drug com- and $1.594-bn in international markets
comparative to recent years. DCAT approval does not allow the applicant petition). Schultz was hired to turn the (a 1% gain year-over-year). As part of Sandoz
Value Chain Insights takes a look to market the generic-drug product are the fi rst approval by the US FDA company around. He oversaw the com- its generics strategy, Teva is seeking to Sandoz, the former generics and
inside the numbers and the key market and postpones the fi nal approval until that permits a manufacturer to market pany’s restructuring and developed the focus on complex, differentiated pro- biosimilars business of Novartis,
moves from the leading generic-drug all patent/exclusivity issues have been a generic drug product in the US. In ensuing strategy of further diversifying ducts, such as drug-device combina- which was spin off by Novartis in
companies. resolved. This level is slightly up from 2023, FDA’s CDER approved 90 fi rst in innovator drugs and optimizing the tions and long-acting injectables. October 2023, completed its fi rst year
recent prior years. In 2022, FDA’s CDER generics, slightly down from 2022, company’s generics portfolio by ratio- as a stand-alone company in 2023. The
Generic-drug approvals in the US approved 914 generic drugs and only when FDA approved 107 fi rst generics, nalizing the company’s generics pro- Viatris company reported full-year 2023 net
In looking at the numbers, how are 776 in 2021, which was a recent low. but on par with 2021 levels, when duct portfolio and moving it away from For its part, Viatris reported 2023 sales of $9.6-bn, up 7% in constant
generic-drug approvals in the US trend- the agency approved 93 fi rst generics less profi table areas to more value-added total revenues of $15.43-bn, compared currencies (up 6% in US dollars). Its
ing? In 2023, the Center for Drug Eva- Among generic-drug approvals, it (see Figure 2). products, such as complex generics, to $16.26-bn for the comparable prior- generics business reported 2023 revenues
luation and Research (CDER) of the US is important to look at “fi rst-generic” biosimilars, and other products with a year period, representing a decrease of $7.4-bn, up 4% in US dollars and
Food and Drug Administration (FDA) approvals, which as the name implies, Key market developments higher barrier to market entry. of $835.8-mn, or 5%. The decline 5% in constant currency. Its biosimi-
But the numbers alone do not tell was principally due to a decline of net lars business reported 2023 revenues of
the full story of the generics market. Francis is now leading the company sales from developed markets, which $2.2-bn, a 15% gain in both US dollars
Always marked by a highly cost-com- and is charged with continuing the decreased by $517.0-mn or 5%, and and constant currencies. This strong
petitive market, several of the leading company’s turnaround, which he plans from net sales from Japan, Australia double-digit biosimilar growth refl ects
generic-drug companies are continuing to do so through its “Pivot to Growth and New Zealand, which collectively the launch of Hyrimoz, a high-con-
a strategy to improve margins, particu- Strategy,” which consists of four main decreased by $207.9-mn or 13%. centration formulation of adalimumab
larly in the US market, through restruc- growth areas: innovative drugs; bio- (reference product AbbVie’s Humira)
turing initiatives and diversifi cation of similars; the company’s core generics Viatris also substantially completed indicated for the treatment of various
product portfolios to more value-added business; and capital allocation to fur- in 2023 a signifi cant restructuring pro- infl ammatory conditions as well as
products. On a geographic basis, North ther reduce debt. gram that was initiated during 2020. As ongoing strong demand for the
America represents a shrinking share of part of the restructuring, the company company’s fi rst-ever biosimilar, Omnitrope
the global generics market value due to With respect to its generics busi- optimized its commercial capabilities (somatropin), a human growth hormone
rising competition and downward pricing ness, in 2023, Teva reported revenues and enabling functions, and closed, product.
pressures. Although the US generics
Fig. 1: Generic drug approvals in the US, 2019-2023 market has begun to stabilize since
Source: Offi ce of Generic Drugs, Center for Drug Evaluation and Research (CDER) Chemical Weekly | Import-Export Data
2019, strong pricing pressures remain.
Market Surveys | Directories
Teva Business Forums | Expositions
Teva is continuing its “Pivot-to-
Growth,” strategy, which the company The only organisation in India catering exclusively to the needs of the entire chemical industry
announced in May 2023 and which
is being led by Richard Francis, who Contact:
became Teva’s President and CEO
in January 2023. He succeeded Kåre SEVAK PUBLICATIONS PVT. LTD.
Schultz, formerly Teva’s CEO, who 602-B, Godrej Coliseum, K.J. Somaiya Hospital Road,
retired, effective December 31, 2022. Behind Everard Nagar, Sion (E),
Schultz had been Teva’s CEO since
2017 and came on board to lead a Mumbai 400 022.
major restructuring plan, which was Phone: +91-22-24044471 / 72
Fig. 2: First generic drug approvals in the US, 2019-2023 announced in late 2017. The plan Email: admin@chemicalweekly.com
Source: Offi ce of Generic Drugs, Center for Drug Evaluation and Research (CDER) addressed declining revenue from the

194 Chemical Weekly May 14, 2024 Chemical Weekly May 14, 2024 195

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