- The first Humira biosimilar, Amgen’s Amjevita, is set to reach the market and kick off a tsunami-sized wave of competition. With eight biosimilar launches coming up this year, including Amgen’s, the world's top-selling medicine is due for a serious showdown. For now, though, AbbVie's immunology blockbuster can reliably scoop up big sales as the other biosim players wait on the sidelines. AbbVie's Humira generated $20.7 billion last year, and market watchers have long wondered how the company will fare after its loss of exclusivity. Back in 2019, the company struck a $63 billion buyout of Allergan in part to reduce its reliance on Humira. Plus, AbbVie has said it expects Skyrizi and Rinvoq to eventually surpass Humira's peak sales level. After Amgen's biosim launch, still to come later this year are Humira biosimilars from Boehringer Ingelheim, Novartis' Sandoz, Organon, Pfizer, Mylan, Coherus and Fresenius Kabi. (Fierce Pharma)
- Legend and J&J said the closely watched phase 3 CARTITUDE-4 trial has hit its goal at an interim analysis. That means Carvykti topped existing standard combination therapies at staving off tumor progression or death in patients with multiple myeloma who had received one to three prior lines of therapy. Before the Carvykti announcement, BMS already revealed the success of the phase 3 KarMMa-3 trial, which is testing Abecma in myeloma patients who had tried two to four prior regimens. Compared with investigator’s choice of combination therapies, Abecma cut the risk of disease progression or death by 51%, according to data shared in an abstract at the upcoming European CAR T-cell meeting. Patients who got Abecma went a median 13.3 months without disease progression versus 4.4 months for standard treatments. Detailed analyses will be shared in February. (Fierce Pharma)
- The generic version of the breast cancer drug, Palbociclib, has slashed treatment costs by 95% in India, medical oncologists told. The branded version of the drug used costs Rs80,000 per month. The generic version, made available from January 17 this year, costs Rs3,800. A patient is advised to take the drug for an average of 18 months. "The availability of generic Palbociclib will spare expenses to the tune of Rs6,858 crore if we consider a minimum of 50,000 patients on the drug for an average of one-and-a-half years in India," said Pune-based oncologist Dr Anantbhushan Ranade. According to the cancer registry in India, around 14 lakh new cancer patients get diagnosed yearly. Of them, around 2.1 lakh are breast cancer patients. Among these, some 1.2 lakh need Palbociclib in combination with hormonal therapies. The entry of the generic medicine became possible after Pfizer's Indian patent on the product expired this month. As many as 14 Indian pharma companies are currently manufacturing or in the process of manufacturing the generic version. (TOI)
- A fourth BTK inhibitor for blood cancer treatment has arrived—but this one is different than the others. Eli Lilly has won an FDA accelerated approval for pirtobrutinib for mantle cell lymphoma (MCL) after at least two prior lines of therapy, including a BTK inhibitor, the company said. The drug will be made available in the U.S. in the coming weeks under the brand name Jaypirca, Lilly said. The Indianapolis pharma is offering Jaypirca at a list price of $21,000 for a 30-day supply, a Lilly spokesperson said. Before Jaypirca, the FDA already approved three BTK inhibitors—AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa. But Jaypirca is different from those products, and Lilly is mainly angling its drug at a different market. While the three earlier products are covalent BTK inhibitors that can’t be used sequentially, Jaypirca is a non-covalent BTK inhibitor. Jaypirca binds to BTK differently and therefore can be used after progression on another BTK inhibitor. This mechanism gives Jaypirca a unique opportunity to treat patients who have failed on another BTK inhibitor, and most blood cancer patients eventually do progress on covalent BTK. The current go-ahead is an accelerated approval, meaning Lilly is on the hook to verify Jaypirca’s clinical benefit. The ongoing phase 3 BRUIN MCL-321 trial serves as the confirmatory study, according to Lilly. The trial is comparing Jaypirca with investigator’s choice of Imbruvica, Calquence or Brukinsa in MCL patients who have received at least one prior line of therapy but are new to a BTK inhibitor. (Fierce Pharma)
- India's domestic pharmaceutical market is estimated to reach $130 billion by 2030 and the pharma industry has sustained its growth momentum after the pandemic, according to the Economic Survey 2022-23. The country's pharmaceutical exports achieved a healthy growth of 24% in FY21, driven by COVID-19-induced demand for critical drugs and other supplies made to over 150 countries, said the survey tabled in Parliament on January 31. “The Indian pharmaceutical industry plays a prominent role in the global pharmaceutical industry," it said adding, India is ranked 3rd worldwide in the production of pharma products by volume and 14th by value. The nation is the largest provider of generic medicines globally, occupying a 20% share in global supply by volume, and is the leading vaccine manufacturer globally with a market share of 60%, it added. On the home front, the Survey said, "India's domestic pharmaceutical market is estimated at $41 billion in 2021 and is likely to grow to 65 billion by 2024 and is further expected to reach $130 billion by 2030." Quality generic medicines at affordable prices have been made available under the Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP) through dedicated outlets known as Janaushadhi Kendras. “Under the PMBJP, until 31 December 2022, more than 9,000 PMBJKs have been opened across the country. At present, the product basket of PMBJP comprises 1759 medicines and 280 surgical devices available for sale," the Survey said. (The Hindu)
The above are based on my own personal research and does not reflect my organisation’s views.
