Company: SNY
Filing Date: 2025-02-13
Form Type: 20-F
Source: 0001121404-25-000010
Chunk: 100

Company: Sanofi
Filing Date: 2025-02-13
Form: 20-F
Chunk 100
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 access, as is currently being observed in particular in the US (but also in other markets around the world). The number of drugs excluded from leading pharmacy benefit managers’ formularies has increased dramatically over the past five years in the US commercial health insurance market, mostly in crowded therapeutic areas. For 2024, the three largest pharmacy benefit managers (PBMs) - Caremark (CVS Health), Express Scripts (Cigna), and OptumRx (United Health Group) - have again each excluded 600 or more drugs from their standard formularies. Formulary exclusions and utilization management are tools used by payers to manage prescription drug costs and leverage their negotiating power with manufacturers; • competition among original and generic products or original biological products and biosimilars, at the end of regulatory exclusivity or patent protection; and • competition among generic or biosimilar products. Generics manufacturers who have received all necessary regulatory approvals for a product may decide to launch a generic version before the patent expiry date, even in cases where the owner of the original product has already commenced patent infringement litigation against the generics manufacturer. Such launches are said to be “at risk” for the owner and the promoter of the generic product because it may be required to pay damages to the owner of the original product in the context of patent infringement litigation; however, such launches may also significantly impair the profitability of the pharmaceutical company whose product is challenged.

| SANOFIFORM 20-F2024 | 41 |

| PART I                             |
| ITEM 4. Information on the Company |

Drug manufacturers also face intra-product competition through parallel trade, where legally permitted. This refers to the practice whereby parallel traders or importers purchase drugs in one country and sell them in another country without the authorization of the original drug manufacturer. This usually occurs in markets where price differences exist due to factors like varying regulations, taxes or exchange rates. The parallel trader or importer will repackage or resize the original product with leaflets in the local language and sell it through an alternative channel at a higher price. This situation is of particular relevance in the European Union single market, where such practices have been encouraged by the current regulatory framework. Some of the risks arising from parallel trade include quality and safety concerns, breach of intellectual property rights and supply chain disruptions (see “Item 3. Key Information — D. Risk Factors”). The industry is also facing a proliferation of falsified and substandard medicines, a problem particularly widespread in low- and middle-income countries. The WHO estimates that 10% of