Pharma IP & Biosimilars Update (May 2026): Landmark Denosumab Approvals and Europe’s Latest SPC Ruling-Safinamide
Pharma IP & Biosimilars Update (May 2026): Landmark Denosumab Approvals and Europe’s Latest SPC Ruling
Introduction
The global pharmaceutical landscape continues to shift as high-stakes biologics face biosimilar competition and European patent courts redefine market exclusivity. This week, we analyse the surge in FDA-approved denosumab biosimilars, a strategic PBM formulary disruption, and a major legal reversal in Germany that leaves generic manufacturers exposed to patent infringement risks
1. The Denosumab Market Explodes: 2026 FDA Biosimilar Approvals
The early months of 2026 have marked an incredibly active period for bone-health therapies
New 2026 Approvals & Dual-Brand Strategies
Boncresa & Oziltus (denosumab-mobz): Approved on January 6, 2026, developed by Amneal and mAbxience
. Amneal is deploying a dual-brand approach to target specific healthcare settings . Boncresa is designated for primary care osteoporosis, while Oziltus focuses on oncology-related skeletal protection . Ponlimsi (denosumab-adet): Approved on March 27, 2026, from Teva Pharmaceuticals
. It covers all indications of the reference product, Prolia, for broad bone-loss treatment .
The Power of Interchangeability
A critical regulatory milestone for these 2026 products is their Interchangeable status
U.S. Denosumab Competitive Landscape
The market has rapidly become one of the most crowded biosimilar spaces in the U.S.
Sandoz: The pioneer, launching interchangeable Jubbonti and Wyost in June 2025 after an Amgen settlement
. Celltrion: Launched Stoboclo and Osenvelt in July 2025, securing interchangeability late last year
. Hikma: Partnered with Gedeon Richter to officially launch Enoby and Xtrenbo on January 19, 2026
. Fresenius Kabi: Rolling out Conexxence and Bomyntra since mid-2025
.
Formulary Disruption Alert: PBMs are accelerating adoption
. Effective April 1, 2026, CVS Caremark dropped the innovator brand Prolia from its major national commercial formularies, replacing it with preferred biosimilars Ospomyv (Sandoz/Samsung) and Stoboclo (Celltrion) . This commercial shift has driven Amgen’s Q1 2026 Prolia sales down by 34% to $727 million, forcing deeper rebate strategies .
2. Global Strategic Collaborations & Biosimilar Litigation
Hengrui Pharma & Bristol Myers Squibb (BMS): The companies announced global strategic collaboration and license agreements to advance 13 early-stage programs across oncology, haematology, and immunology
. Stelara Biosimilar Injunction Denied: In ongoing litigation involving J&J and Samsung Bioepis, the Third Circuit affirmed the denial of an injunction against Samsung’s Stelara biosimilar, Pyzchiva
. The court ruled that J&J failed to show immediate, irreparable injury regarding a sublicense granted to Quallent (a Cigna subsidiary) .
3. Intellectual Property: German Court Grants Safinamide SPC
In a landmark legal victory for innovators, the German Federal Patent Court has overturned a negative assessment by the German Patent and Trademarks Office (DPMA)
The Case: Xadago® (Safinamide)
On April 27, 2026, the court granted a Supplementary Protection Certificate (SPC) to Newron and Zambon for the Parkinson’s disease drug Xadago
[Timeline: EP 1613296 Basic Patent Expiry (April 2024) ---> Retroactive SPC Extension Granted ---> New Expiry (April 2029)]
Immediate Impact on Generic Manufacturers
This retrospective monopoly extension creates severe immediate operational and financial risks for generic players
Product Withdrawals: Firms like Stada and Vivanta Generics, which launched or prepared generic safinamide in early 2026, face mandatory product withdrawals to avoid ongoing patent infringement
. Severe Financial Damage Claims: The originators can now legally seek retroactive damages for any generic sales made in Germany between April 2024 and the April 2026 decree date
.
This ruling emphasises the powerful role SPCs play in European life-cycle management and serves as a stern warning to generic portfolios launched immediately upon basic patent expiry
------------XX-----------XX---------------------
Contents
Biosimilar approvals in 2026 (Jan-April-2026)
General information
Hengrui Pharma and Bristol Myers Squibb Announce Strategic Agreements to Advance Innovative Medicines Across Oncology, Hematology, and Immunology
Third Circuit Affirms Denial of Stelara Biosimilar Injunction
Intellectual Property
Legal Victory: German Federal Patent Court Grants SPC for Safinamide
Biosimilar approvals in 2026 (Jan-April-2026)
We follow FDA approvals for Biosimilars.
The early months of 2026 have been a busy period for the denosumab market, with the FDA approving three significant biosimilars that enhance patient access to essential bone-health therapies.
On January 6, 2026, the FDA approved denosumab-mobz, marketed by Amneal Pharmaceuticals under the brand names Boncresa and Oziltus. These two products serve distinct clinical needs: Boncresa is indicated for the treatment of osteoporosis in postmenopausal women and men at high risk of fractures, while Oziltus is specifically approved for oncology-related indications, such as preventing skeletal-related events in patients with bone metastases. Amneal's dual-brand strategy allows for targeted therapeutic use across both primary care and speciality oncology settings.
Teva Pharmaceuticals received FDA approval for denosumab-adet (Ponlimsi) on March 27, 2026. Ponlimsi is approved for all indications of its reference product, Prolia, covering a broad spectrum of bone loss conditions, including glucocorticoid-induced osteoporosis and bone mass increase in men receiving certain cancer treatments. A critical factor in these 2026 approvals is their Interchangeable status, which permits pharmacists to substitute these biosimilars for the reference biologics without requiring a new prescription from the provider.
This regulatory milestone is expected to significantly drive down healthcare costs by fostering intense price competition in the denosumab space.
The denosumab market is among the most crowded and competitive biosimilar landscapes in the U.S. Here is the current status of other players of denosumab in the market:
1. Sandoz (The First Mover)
Sandoz was the pioneer in this space, receiving the first-ever FDA approvals for denosumab biosimilars on March 5, 2024.
- Products: Jubbonti (referencing Prolia) and Wyost (referencing Xgeva).
- Status: Both were launched in June 2025 following a settlement with Amgen and are interchangeable.
2. Celltrion (Stoboclo and Osenvelt)
Celltrion received FDA approval for its denosumab biosimilars (CT-P41) in early 2025.
- Products: Stoboclo (referencing Prolia) and Osenvelt (referencing Xgeva).
- Status: These products were launched in the U.S. in July 2025 and were granted interchangeability in late 2025.
3. Hikma (Partnered with Gedeon Richter)
Hikma handles the U.S. commercialisation for biosimilars developed by Gedeon Richter.
- Products: Enoby (referencing Prolia) and Xtrenbo (referencing Xgeva).
- Status: Approved in September 2025, Hikma officially launched these products in the U.S. on January 19, 2026, after settling patent litigation with Amgen.
4. Fresenius Kabi (Conexxence and Bomyntra)
Fresenius Kabi secured its market position with approvals in March 2025.
- Products: Conexxence (referencing Prolia) and Bomyntra (referencing Xgeva).
- Status: Following a global settlement with Amgen, Fresenius began its U.S. rollout in mid-2025.
5. CVS Health (The Payer/Formulary Driver)
CVS does not manufacture biosimilars, but through CVS Caremark (its PBM) and Cordavis (its commercialisation arm), it has been the primary driver of market adoption.
- Action: Effective April 1, 2026, CVS Caremark removed the brand-name Prolia from its major national commercial formularies.
- Preferred Products: They replaced the reference product with Ospomyv (Sandoz/Samsung Bioepis) and Stoboclo (Celltrion). This shift is expected to move massive patient volume toward biosimilars.
The price information for 60 MG/ML from Globaldata is as follows
Although exact biosimilar sales information is not publicly available, Amgen reported that Prolia (60mg) sales fell to $727 million in Q1 2026, a 34% decline from the $1.1 billion reported in the previous year. This drop is primarily attributed to lower net selling prices as Amgen offers deeper rebates to maintain formulary positions against new competitors.
We will cover two other Biosimilar approvals so far in CY 2026 next week.
General information
Hengrui Pharma and Bristol Myers Squibb Announce Strategic Agreements to Advance Innovative Medicines Across Oncology, Hematology, and Immunology
Hengrui Pharma ("Hengrui") (600276.SH; 01276.HK) and Bristol Myers Squibb ("BMS") today announced the companies have entered into global strategic collaboration and license agreements to advance a portfolio of 13 early stage programs in oncology, hematology and immunology, with the goal of accelerating discovery and development of innovative medicines for the benefit of patients worldwide.
News here
Third Circuit Affirms Denial of Stelara Biosimilar Injunction
Litigation between Johnson & Johnson and Janssen (“J&J”) and Samsung Bioepis (“Samsung”) involving Samsung’s Stelara biosimilar, PYZCHIVA (ustekinumab-ttwe) (previously known as SB17), was resolved via a settlement agreement in 2023. Under the terms of the agreement, Samsung received a limited patent license, prohibiting Samsung from sublicensing with a few exceptions, one of which was for sublicenses it could grant to “commercialization partners to import, sell and offer to sell SB17 Product on behalf of [Samsung].” In 2025, Samsung sublicensed PYZCHIVA to Quallent, a subsidiary of Cigna.
The Third Circuit held that J&J had not provided sufficient evidence to show immediate, irreparable injury.
News here
Intellectual Property
Legal Victory: German Federal Patent Court Grants SPC for Safinamide
A Supplementary Protection Certificate (SPC) is an intellectual property right in Europe that extends a patent term for specific medicinal products. It is designed to compensate for the period of patent life lost during the lengthy clinical trials and regulatory approval processes required before a drug can be marketed. By granting up to five additional years of protection, the SPC ensures innovative pharmaceutical companies can recoup their research and development investments. Essentially, it provides a bonus period of exclusivity that begins once the basic patent expires.
The Safinamide Case: Overturning the DPMA
Following a negative assessment by the German Patent and Trademarks Office (DPMA), the pharmaceutical companies Newron and Zambon achieved a significant victory. On 27 April 2026, the 14th Senate of the German Federal Patent Court granted an SPC for the Parkinson's drug Xadago (active ingredient safinamide).
The court’s decision (14 W (pat) 23/24) overturns the DPMA’s initial rejection and extends protection for the period between 8 April 2024 and 7 April 2029. This SPC applies to the basic patent EP 1613296, which technically expired in April 2024.
The claim of EP 296 covers the use of a first agent selected from safinamide from 0.5 to 1, 2, 3, 4 or 5 mg/kg/day in combination with levodopa/PDI, for the preparation of a medicament as a combined product for simultaneous, separated or sequential use for the treatment of Parkinson's Disease.
In its ruling, the court clarified that safinamide is protected both alone and in combination with other drugs, applying the two-stage test set out in the CJEU Teva/Gilead decision.
Market Consequences: The Fate of Generics in Germany
The retrospective grant of this SPC has immediate and severe implications for generic manufacturers in Germany. Based on current market data, companies such as Stada and Vivanta Generics have already launched generic versions of safinamide or have approvals scheduled for early 2026.
The general price comparison in the German market is as follows. This should be seen only as a rough guide, since the price of any medical product in Germany involves several nuances.
However, due to this ruling, which effectively prolongs the SPC's monopoly rights until April 2029, any generic safinamide products on the market, such as those from Stada and Vivanta, now infringe on a valid intellectual property right. The potential consequences for these generic companies include:
- Mandatory Product Withdrawal: Generic manufacturers will likely be forced to immediately withdraw their products from the German market to avoid further legal action.
- Damage Claims: Newron and Zambon may seek significant financial damages for any generic sales made during the period from the patent's original expiry in April 2024 to the date of the SPC grant.
- Injunctions: Parallel infringement proceedings are already pending in Germany and the Netherlands, where the originators have been successful to date, suggesting that legal enforcement will be swift and robust.
This ruling reinforces Xadago's market position and serves as a reminder of the powerful role SPCs play in the European pharmaceutical landscape.
News here
#Biosimilars, #PharmaIP, #PatentLitigation, #RegulatoryAffairs, #MarketAccess, #GenericDrugs
