Generics Bulletin
Health Canada’s proposal to no longer require biosimilar manufacturers to prove the safety and efficacy of their product through Phase III clinical trials marks a pivotal change in Canada’s regulatory approach.
As UK players face increasing competitive pressures on “vanilla” generics – including potential new market entrants from China – Ben Ellis, Lupin’s UK and Ireland general manager, explains how the company is focusing on more complex opportunities that require a hybrid generic and branded mindset.
Teva has agreed to partner with China’s Fosun Pharma to develop TEV-56278, a targeted cancer immunotherapy, marking the next step in its continued pivot from its generics roots toward complex biologics and innovative oncology treatments. The deal covers key Asian markets, including mainland China, w
The International Generic and Biosimilar medicines Association has set out three priority areas that it says should be considered by G7 leaders at the current summit in Alberta, Canada, as part of efforts towards ensuring access to health.
Sun’s founder hands top job to company longtimer Kirti Ganorkar as the firm implements a “structured and forward-looking” succession plan, while Richard Ascroft will lead the Indian drugmaker’s North America business.
As multiple molecules experienced triple-digit percentage price rises in May, pioglitazone once again led the way after already topping our table of price increases in April.
In an exclusive interview, Iconovo CEO Johan Wäborg outlines the company’s strategy to become a leader in dry powder inhalation by focusing on platform development, reformulated therapies, and B2B licensing, with a plan to break even by 2027.
Lupin is planning to expand its footprint in China through a deal for a tiotropium dry powder inhaler with local player Sino Universal Pharmaceuticals.
Outlook Therapeutics has started to conquer European markets with its ophthalmic version of bevacizumab. Meanwhile, across the pond in the US, it awaits the FDA’s decision, again.
As Endo and Mallinckrodt continue to work towards consummating the merger they announced earlier this year, the pair have revealed further organizational details of their combined generics and sterile injectables business, which is set to be spun off after the merger is complete.
Stephan Eder has left Stada and stepped down as president of Medicines for Europe, with the company announcing plans for his replacement and the association naming Polpharma CEO Markus Sieger as the association’s new interim president.
Xbrane Biopharma is partnering with India’s OneSource Specialty Pharma to manufacture its biosimilars, including its much-delayed ranibizumab product Ximluci. The move follows a SEK240m funding round and strategic refocus on commercialization after divesting key R&D assets to Alvotech.
After signing a deal with Avenacy at the end of last year, Hyloris has now announced the approval of its intravenous formulation of tranexamic acid, which is used as a hemostatic agent.
Generics Bulletin reviews global regulatory developments across the world.
Regeneron says it is closely watching Amgen’s Pavblu 2mg aflibercept biosimilar, which is gaining traction via financial incentives to physicians as “the only differentiator” to its Eylea reference brand. Meanwhile, Regeneron is aiming to boost Eylea HD uptake amid regulatory setbacks.
The group had been laid off as part of the 1 April reduction-in-force, which lead to missed guidance publication deadlines.
Stada’s Specialty division was boosted by the firm’s launch last year of a European Stelara biosimilar, even as generics growth remained muted in Q1.
Formycon is preparing to start a new era – entering Latin America with its ranibizumab biosimilar, which is expected to be a “good contributor” to the firm’s finances.
Hot on the heels of a recent alliance in Italy, biosimilars developer mAbxience has struck another deal – this time partnering with Corapharm in south-east Europe.
Ahead of a bench trial beginning in February 2026, Lupin has become the latest ANDA sponsor to settle patent-infringement litigation over Harmony Biosciences’ Wakix (pitolisant hydrochloride), which has been touted as a potential blockbuster by the end of the decade.