European regulators are finalizing a package of laws that will force drugmakers to reckon with generic and biosimilar competition sooner, according to reporting on new legislation. The changes tighten procedural hurdles companies have used to delay market entry by competitors, and include provisions that may particularly affect developers of rare-disease and orphan drugs. Companies with small-patient populations or niche biologics will likely need to accelerate lifecycle planning and patent strategies, and regulators may see a quicker transition from exclusivity to competition. The legislative shift aims to balance access and innovation; drug developers and investors will be watching implementation timelines and transitional provisions closely.