It's difficult to create innovative drugs with high thresholds, and generics are highly competitive with few barriers, leading to excessive competition. This phenomenon has caused more and more companies to turn their attention to the market for modified new drugs, creating a new path between complete innovation and imitation. Due to the characteristics of lower R&D risks, shorter development cycles and higher returns, this niche market of modified new drugs is gradually drawing people's attention. Although the development of modified new drugs in China started relatively late, they have benefited from better safety, effectiveness, and compliance. Driven by factors such as the national policy's emphasis on clinical value and the upgrading of novel preparation technology, the market size of modified new drugs has rapidly grown. Improving the original dosage forms to address unmet clinical needs and extend the product life cycle is a major R&D approach for modified new drugs at present.
The recent approval of several new dosage forms of blockbuster drugs has confirmed this point to some extent. Last month, FDA officially approved a new dosage form (Entresto sprinkle) of Novartis's blockbuster cardiovascular product Entresto (Sacubitril Valsartan Sodium, Entresto). Entresto Sprinkle is supplied in the form of capsules with film-coated oral granules inside for oral administration. It is approved in two specifications, containing 6mg sacubitril and 6mg valsartan; or containing 15mg sacubitril and 16mg valsartan. It is worth noting that Entresto achieved a staggering sales volume of USD 6.035 billion globally last year. Similarly, FDA also approved Abbvie's new oral solution dosage form of Upadacitinib (Rinvoq) this month, with the brand name Rinvoq LQ. Last year, the global sales volume of Upadacitinib also reached USD 3.969 billion.
After considering the approval of the new dosage form of Sacubitril Valsartan Sodium and Upadacitinib, we can find that original manufacturers are making efforts to extend the product life cycle. When the patents on key compounds of the two drugs expire in recent years, the approval of new dosage forms will deepen the protection of the products and delay the speed of market segmentation by generics.
Throughout history, whether it is Risperidone and paliperidone palmitate that shine in the field of psychiatry or the classic drug Paclitaxel in the field of tumor, they have all ushered in a new engine of growth after continuous dosage form upgrades. And with the continuous development of preparation technology platforms such as slow release control, microspheres, liposomes, and inhalation preparations, more possibilities are added to the dosage form improvement. Pharmaceutical dosage form improvement has been on the fast track of high-speed development, whether it is driven by products or preparation technology.
01 Differentiation benchmark
Opening the global drug sales data for 2023, it is not difficult to find that all good times don't last long. The former king of medicine Humira saw a sharp decline in sales volume under the impact of patent cliff, and Keytruda took over as the new king of medicine. Meanwhile, several blockbuster products including Lenalidomide, Etanercept, and Ibrutinib have continued to decline under the erosion of generics after their patents expired. Modifying the original dosage forms is currently a strategy for many drugs to extend their product life cycle. Both changing Keytruda into subcutaneous preparation and changing semaglutide into oral preparation reflect the wisdom of the original drug manufacturers.
Among numerous modified dosage forms, the long-acting injectable suspensions of paliperidone palmitate undoubtedly stands out as the most impressive one, achieving an astonishing global sales volume of USD 4.115 billion in 2023. Paliperidone is a kind of atypical antipsychotics that is the primary metabolic product of Risperidone. INVEGA, a daily oral preparation, was approved in the United States in 2006. INVEGA SUSTENNA, a monthly preparation, was approved in the United States in 2009. INVEGA TRINZA, a three-month preparation, was approved in the United State...
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