2026 Biopharma News: Filkri Approval, Langlara Interchangeability, and CDSCO ONDLS Mandate

Biopharma Industry Insights 2026: New Biosimilar Approvals & Key IP Rulings

The biopharmaceutical landscape continues to evolve rapidly in 2026 with critical regulatory updates, market entries, and high-stakes intellectual property decisions. In this post, we break down the most significant developments from the latest industry updates, including two major USFDA biosimilar clearances, crucial export compliance changes in India, and a landmark European Patent Office (EPO) ruling.

1. USFDA Expands Oncology Supportive Care with Filkri Approval

The USFDA has officially expanded the oncology landscape by approving Filkri (filgrastim-laha). Developed by Accord BioPharma (the U.S. speciality division of India-based Intas Pharmaceuticals), Filkri serves as a biosimilar referencing Amgen’s blockbuster drug, Neupogen.

Key Details & Market Impact:

• Indications: It is a short-acting granulocyte colony-stimulating factor (G-CSF) designed to stimulate neutrophil production and combat severe neutropenia in patients undergoing myelosuppressive chemotherapy.

• Formulation: Supplied in single-dose prefilled syringes 300 mcg/0.5 mL and 480 mcg /0.8 mL ~ approx 0.6 mg/mL.

• Manufacturing Hub: Produced at Intas Pharmaceuticals' state-of-the-art facility in Ahmedabad, India.

• Competitive Landscape: Filkri is the fifth Neupogen biosimilar approved in the U.S., entering a highly mature market segment where biosimilars already command over 75% of the total filgrastim volume. It will compete directly against Sandoz's Zarxio (which dominates with a 55%–60% market share) and Pfizer's Nivestym.

2. Langlara Marks a Historic First for Chinese-Developed Insulin

In another major regulatory milestone, the USFDA approved Langlara (insulin glargine-aldy), a long-acting basal insulin biosimilar referencing Sanofi’s blockbuster Lantus. Developed through a strategic partnership between Sunshine Lake Pharma (HEC Group) and Lannett Company, Langlara achieves a historic milestone as the first-ever Chinese-developed insulin product to receive USFDA clearance.

Strategic Significance:

• Interchangeable Designation: Crucially, the FDA granted Langlara an interchangeable designation. This legally authorises pharmacists to substitute it for Lantus at the point of dispensing without needing a new prescription from a healthcare provider.

• Supply Architecture: It is supplied in a 3 mL single-patient-use prefilled pen (the Langlara Pen) matching Sanofi’s Lantus SoloStar design.

• Commercialisation Pipeline: The product will be distributed via Lanexa Biologics (Lannett’s specialised biologics subsidiary), which is planned to spin off as an independent commercial platform following Aurobindo Pharma’s pending acquisition of Lannett.

3. CDSCO Mandates Online Submissions for CoPP Issuance

For manufacturers exporting from India, regulatory compliance workflows have shifted significantly. The Central Drugs Standard Control Organisation (CDSCO) has mandated that all applications for the World Health Organisation-Good Manufacturing Practices (WHO-GMP) Certificates of Pharmaceutical Products (CoPP) must be submitted online.

• The Digital Portal: Physical submissions have been fully replaced by the Online National Drug Licensing System (ONDLS) portal.

• Why It Matters: CoPP is a vital document required for exporting medicines to international markets. In India, it is issued only after a mandatory joint inspection of the manufacturing facility by CDSCO officials and the State Licensing Authority (SLA). Companies must adapt quickly to the ONDLS platform to avoid export delays.

4. IP Victory: EPO Upholds Lundbeck's Patent for Vortioxetine HBr

On the intellectual property front, the Technical Board of Appeal of the European Patent Office (EPO) issued a major judgment in Case T 0388/24. The Board dismissed an appeal by generic manufacturer Generics (UK) Limited, upholding H. Lundbeck A/S’s patent (EP 3615518) for the manufacturing process of the stable vortioxetine hydrobromide alpha-form.

The Core of the Ruling:

• The Dispute: Generics (UK) Limited challenged the patent on the grounds of insufficiency of disclosure, arguing that the mandatory addition of a C1–C3 carboxylic acid played no technical role in controlling the polymorph.

• The Evidence: The Board rejected the generic opponent's arguments, noting that examples utilising HBr dissolved in acetic or propionic acid consistently and successfully yielded pure alpha-form precipitates, whereas reference examples without the carboxylic acid failed.

• The Impact: This definitive ruling secures Lundbeck’s robust manufacturing and regulatory barriers against generic entries targeting alternative crystalline process variations within the European Union.

Global Market Expansion Highlight

In other global news, Samsung Bioepis has launched its Ustekinumab biosimilar (Ustekinumab BS 45 mg Syringe for S.C. Injection, NIPRO) in Japan. This marks their first-ever product launch in Japan, executed through a strategic partnership with Nipro Corporation, expanding access to treatments for chronic autoimmune conditions.

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Contents

Biosimilar approvals in 2026 (Jan-April-2026)

General information

Samsung Bioepis Launches Ustekinumab Biosimilar, Marking Its First Product Launch in Japan

ACT FAST ON COPP ISSUANCE

Intellectual Property

EPO Technical Board of Appeal Upholds Lundbeck’s Patent for Vortioxetine HBr Alpha-Form (Case T 0388/24)

Biosimilar approvals in 2026 (Jan-April-2026)

Last week, we covered all denosumab biosimilar approvals; this week, we will review the remaining approvals by the USFDA.

Filkri (filgrastim-laha)

On February 17, 2026, the USFDA expanded the oncology supportive care landscape by approving Filkri (filgrastim-laha), a biosimilar referencing Amgen’s blockbuster Neupogen. Developed by Accord BioPharma, the U.S. speciality division of India-based Intas Pharmaceuticals, Filkri is a short-acting granulocyte colony-stimulating factor (G-CSF) indicated to stimulate neutrophil production and combat severe neutropenia in patients undergoing myelosuppressive chemotherapy. 

Backed by rigorous comparative pharmacokinetic, pharmacodynamic, and safety data, Filkri enters an incredibly mature, highly adopted market segment where biosimilars already command over 75% of the total filgrastim volume in the United States. Crucially for Accord, this approval completes their competitive G-CSF portfolio, allowing them to market both a short-acting option (Filkri) alongside their long-acting pegfilgrastim asset, positioning the manufacturer as a comprehensive, cost-effective partner for oncology health networks.

Key points to note:

• Approval Date: February 17, 2026 (The FDA officially signed the BLA on January 15, 2026, with the public market rollout announced in February).
• Formulation: Single-dose prefilled syringes (300 mcg/0.5 mL and 480 mcg/0.8 mL ~ 0.6 MG/ML).
• Manufacturing Site: Produced at Intas Pharmaceuticals' facility in Ahmedabad, India.
• Market: It is the fifth Neupogen biosimilar approved in the U.S. (following Zarxio, Nivestym, Releuko, and Nypozi).

Some price information from GlobalData for the US market is as follows. One should consider this price information only indicative and directional. Prices in the US depend on many factors.

Langlara (insulin glargine-aldy), 

On April 29, 2026, the USFDA approved Langlara (insulin glargine-aldy), a long-acting basal insulin biosimilar referencing Sanofi’s blockbuster Lantus. Developed through a strategic partnership between Sunshine Lake Pharma (the pharmaceutical arm of HEC Group) and Lannett Company, Langlara is indicated for glycemic control in both adult and paediatric patients with Type 1 diabetes and in adults with Type 2 diabetes.

Crucially, the FDA granted Langlara an interchangeable designation, giving pharmacists the legal authority to substitute it for Lantus at the point of dispensing without needing a new prescription or intervention from the healthcare provider. Supported by a comprehensive data package confirming comparable pharmacokinetic, pharmacodynamic, and safety profiles to the reference product, Langlara is the third interchangeable insulin glargine approved in the United States, after Semglee and Rezvoglar.

In terms of commercialisation, the product will be distributed solely through Lannett's specialised biologics subsidiary, Lanexa Biologics, which is planned to spin off as an independent commercial platform following Aurobindo Pharma’s pending acquisition of Lannett.

Key points to note:

• Approval Date: April 29, 2026 (Officially finalised via BLA 761412).
• Formulation: 100 units/mL injection for subcutaneous use, supplied in a 3 mL single-patient-use prefilled pen (the Langlara Pen, mirroring Sanofi’s Lantus SoloStar pen architecture).
• Manufacturing Site: Manufactured under U.S. License No. 2343 at the YiChang HEC ChangJiang Pharmaceutical Co., Ltd. facility located in Yidu, Hubei Province, China (the biopharmaceutical arm of HEC Group).
• Market: It is the third interchangeable insulin glargine approved in the United States, following the approvals of Mylan/Biocon’s Semglee (insulin glargine-yfgn) in 2021 and Eli Lilly’s Rezvoglar (insulin glargine-aglr) in 2022. It is also the first-ever Chinese-developed insulin product to receive US FDA clearance.

General information

Samsung Bioepis Launches Ustekinumab Biosimilar, Marking Its First Product Launch in Japan

• Ustekinumab BS 45 mg Syringe for S.C. Injection「NIPRO」 is now available in Japan, after its listing under the National Health Insurance (NHI) Drug Price Standard
• Marks first launch in Japan through partnership with NIPRO CORPORATION
• Samsung Bioepis continues to expand its global presence, widening access to life-enhancing treatments for patients with chronic autoimmune conditions.

News here

ACT FAST ON COPP ISSUANCE

Effective from August 15, 2025, the Central Drugs Standard Control Organisation (CDSCO) had mandated that applications for the World Health Organization-Good Manufacturing Practices (WHO-GMP) Certificates of Pharmaceutical Products (CoPP) must be submitted online only through the Online National Drug Licensing System (ONDLS) portal. The purpose of this mandate was to streamline approvals by replacing physical submissions with the ONDLS which serves as a single window for various drug licenses and certificates. CoPP is a critical document required for exporting medicines to international markets. It is a document issued by a country's drug regulatory authority, certifying that a specific drug is manufactured according to WHO GMP standards, enabling its registration and sale in other countries. In India, the CoPP is issued following a mandatory joint inspection of the manufacturing facility by the officials from the CDSCO and the state licensing authority (SLA).

News here

Intellectual Property 

EPO Technical Board of Appeal Upholds Lundbeck’s Patent for Vortioxetine HBr Alpha-Form (Case T 0388/24)

Introduction

In a significant decision, the Technical Board of Appeal of the European Patent Office (EPO) issued its judgment on February 25, 2026, regarding Case T 0388/24. The Board dismissed the appeal filed by generic manufacturer Generics (UK) Limited, upholding H. Lundbeck A/S’s patent for the manufacturing process of the stable vortioxetine hydrobromide alpha-form. 

This ruling reinforces Lundbeck’s intellectual property protection over vortioxetine, a key major blockbuster medication utilised globally for treating severe depression and generalised anxiety disorders. 

The Core of the Dispute: Process for Vortioxetine HBr Alpha-Form

The dispute centred on European Patent No. 3615518, held by the respondent, H. Lundbeck A/S. The appellant, Generics (UK) Limited, sought to set aside the Opposition Division's previous decision, which had rejected its original challenge. The generic opponent argued a single main ground on appeal: insufficiency of disclosure under Article 100(b) EPC. 

The patent's main request features a process characterised by specific X-ray powder diffraction (XRPD) reflections (5.85, 9.30, 17.49, and 18.58 [2 theta] + 1). The manufacturing steps require

1. Obtaining a solution of vortioxetine in toluene (purity >90% ). 

2. Mixing the solution with HBr and a C1 –C3 carboxylic acid at a temperature above 10 degree C

3. Collecting the isolated crystalline precipitate. 

Key Legal Arguments & The Board's Findings

The Critical Role of C1 –C3 carboxylic acid 

The appellant contested that the claimed process failed to reliably produce the pure alpha-form across its entire scope. They claimed that the carboxylic acid played no technical role in controlling the polymorph. Instead, they argued that the success of the process relied entirely on using non-aqueous or non-gaseous HBr, a feature not explicitly limited in Claim 1. 

The Board of Appeal rejected this argument, pointing directly to the examples filed with the application. In examples 6–10 and 12–13, utilising HBr dissolved in acetic or propionic acid successfully and consistently yielded pure alpha-form precipitates. Conversely, reference examples using aqueous or gaseous HBr alone in toluene failed to yield the product. 

Crucially, comparing example (5) (HBr gas alone) with example (6) (HBr in acetic acid) showed that adding the C1–C3 carboxylic acid actively controlled the polymorphic outcome, turning a synthesis failure into a clear success. On the balance of probabilities, the Board found that polymorphic control would be achieved even if aqueous or gaseous forms were mixed alongside the mandatory carboxylic acid. 

The Critical Mixing Temperature Parameter (> 10 °c )

Generics (UK) Ltd. further argued insufficiency based on reference examples 11 and 14, in which a toluene mixture was heated to 10 °C before HBr in acetic acid was added quickly. They maintained that the exothermic reaction would naturally push temperatures above 10 °C, yet failed to produce the alpha-form, indicating an unrepeatable process. 

The Board dismissed this assertion on a procedural ground. In reference examples 11 and 14, the mixture was immediately cooled in an ice bath after the rapid addition, meaning the reagents were not truly mixed at a sustained temperature above 10 °C. In successful example 6, the addition happened at room temperature before any cooling commenced.

This explicit variance provided a person skilled in the art with definitive instructions on how to achieve successful polymorphic crystallisation: namely, by establishing a starting reaction temperature above 10 °C. 

Final Order: A Victory for Lundbeck’s Lifecycle Management

Because the patent provided clear, actionable guidance on selecting the proper crystallisation pathways and thermal controls, the Board concluded that the specification met all requirements for sufficiency of disclosure under Article 83 EPC. 

Consequently, Technical Board of Appeal ordered that the appeal be dismissed, maintaining the patent exactly as granted. This decision secures Lundbeck’s robust regulatory and manufacturing barrier against generic entries targeting alternative crystalline process variations within the European Union. 

Decision here

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