On 8 December 2025, Celltrion announced that it intends to expand its biosimilar pipeline by “internalising” hyaluronidase-based subcutaneous delivery (SC) formulation technology.  According to Celltrion, its SC technology involves temporarily decomposing hyaluronic acid present in subcutaneous tissues to facilitate drug diffusion.

Celltrion’s announcement states that it has been conducting clinical trials for Herzuma® SC (CT-P6 SC), biosimilar to Roche’s Herceptin® SC (trastuzumab hyaluronidase, marketed in the US as Herceptin Hylecta™) since February 2025 and plans to submit applications for approvals of the Herzuma® SC formulation to domestic and foreign regulatory agencies in the first half of 2026.

Herzuma® was launched in Europe in 2018 and in the US in March 2020.

Celltrion developed the world’s first subcutaneous injection of infliximab, Remsima SC®/Zymfentra®, which was launched in Europe in 2020 and in the US in 2024.

On 6 December 2025, Biocon Limited announced that Biocon Biologics will be integrated into it, becoming a wholly owned subsidiary of the company upon completion of the transaction, expected to occur by 31 March 2026.

Under the proposed transaction, Biocon Limited will acquire the minority stakes in Biocon Biologics currently held by Serum Institute Life Sciences, Tata Capital Growth Fund II and Activ Pine LLP, through a share swap of 70.28 Biocon shares for every 100 Biocon Biologics shares, reportedly valuing Biocon Biologics at USD 5.5 billion.  Biocon will also acquire the residual stake held by Mylan Inc (Viatris) for USD 815 million, with a capital raising of USD 500 million through Qualified Institutional Placement approved by Biocon Limited’s Board (subject to shareholder approval) to help fund that acquisition.

According to Biocon, the integration will strengthen Biocon’s global position “to lead in key therapeutic areas” of diabetes, oncology and immunology.  In particular, Biocon considers that it is “uniquely poised to address the rapidly expanding ‘diabesity’ market” as the “only company operating globally with both biosimilar insulins and generic versions of complex peptides, including GLP-1s”.  Biocon’s Semglee® was the first biosimilar approved in the Unites States as interchangeable to Sanofi’s Lantus® (insulin glargine) (July 2021).

On 5 December 2025, Korea’s HIT News reported that Samsung Bioepis has successfully overturned a preliminary injunction granted to Regeneron and Bayer which was preventing Korean sales of Samsung Bioepis’ Afilivu® (SB15), biosimilar to Regeneron/Bayer’s Eylea® (aflibercept).

The ruling of the Seoul High Court’s Civil Division, finding in favour of Samsung Bioepis, follows an October 2025 decision of the Korean Patent Court invalidating a Regeneron patent for ophthalmic formulations of aflibercept (the Korean equivalent to US Patent No. 11,084,865).

Afilivu® was the first aflibercept biosimilar approved in Korea in February 2024.  In April 2024, it was reported that Samil Pharmaceutical would launch Samsung Bioepis’ aflibercept biosimilar in the Korean market from 1 May 2024.  However, that launch was disrupted by the preliminary injunction.  Following the appeal decision, Samsung Bioepis/Samil can now resume distribution of Afilivu® in Korea.

On 29 January 2025, the US Court of Appeals for the Federal Circuit refused to overturn a preliminary injunction preventing Samsung Bioepis from launching its aflibercept biosimilar in the US without a licence from Regeneron.  This ruling affirmed an earlier decision of the US District Court for the Northern District of West Virginia in June 2024, finding that Samsung Bioepis infringed, and had failed to raise a substantial question of invalidity of, Regeneron’s US Patent No. 11,084,865 regarding ophthalmic formulations of aflibercept.

On 4 December 2025, Formycon and MS Pharma announced that they have entered into an exclusive licensing and supply agreement for the commercialisation of FYB206, biosimilar to MSD’s Keytruda® (pembrolizumab) in the MENA region.

Under the agreement, Formycon will receive an upfront payment and will be eligible for further payments subject to certain development and regulatory milestones.  Formycon will also receive a share of the gross profits generated by sales of the biosimilar in the MENA region.  The agreement further includes an option for future technology transfer.

According to Formycon, the licensing deal with MS Pharma represents the “start of the commercial partnering activities” for FYB206, with further agreements for additional regions and countries to follow.

Formycon commenced an integrated Ph1/3 study in June 2024 to demonstrate PK similarity of FYB206 with Keytruda® in patients with Stage IIB/IIC or Stage III melanoma. On 10 July 2025, Formycon announced that it had completed patient enrolment.  Formycon expects results to be available in Q1 2026.  Formycon had originally intended to conduct a parallel Phase 3 trial to compare the safety and efficacy of FYB206 with Keytruda® in NSCLC.  However, in February 2025, Formycon announced the premature termination of the Phase 3 trial on the basis that the trial was not necessary to obtain US approval of FYB206.

Formycon and MS Pharma have previously partnered on the commercialisation of biosimilars in the MENA region, including FYB202/Otulfi® (ustekinumab), FYB203 (aflibercept) and FYB201/Ravegza® (ranibizumab).

Bioéticos claimed to have launched the first pembrolizumab biosimilar in Paraguay in August 2025 under the name Pembrolizumab Bioéticos.  In November 2025, Biocad’s Pembroria™ (pembrolizumab) was reportedly approved in Vietnam.  A number of other pembrolizumab biosimilars are currently in clinical trials, including by Samsung Bioepis, Amgen, mAbxience, Sandoz, Celltrion, Bio-Thera and BioNTech.  Alvotech and Dr Reddy’s have entered into a global collaboration and licence agreement to co-develop, manufacture and commercialise a biosimilar to Keytruda®.

On 4 December 2025, New Zealand’s Medsafe approved Celltrion’s Avtozma®, biosimilar to Roche’s Actemra® (tocilizumab), in vial (intravenous) and pre-filled syringe (subcutaneous) presentations, making Avtozma® the first tocilizumab biosimilar approved in New Zealand.

Avtozma® has previously been granted marketing authorisation in a number of other regions, including as the first tocilizumab biosimilar approved in Australia (May 2025) and Japan (September 2022), and will be considered for listing on Australia’s PBS at PBAC’s November 2025 meeting.

Avtozma® was the third tocilizumab biosimilar approved in the US (January 2025), and was subsequently launched in an IV formulation in October 2025.  Biogen/Bio-Thera’s Tofidence®/BAT1806 was the first US approved tocilizumab biosimilar (IV formulation, September 2023; launched May 2024), followed by Fresenius Kabi’s Tyenne® (SC formulation, March 2024; IV formulation launched April 2024; SC formulation launched July 2024).

In February 2025, Avtozma® became the third tocilizumab biosimilar approved in the EU, following Fresenius Kabi’s Tyenne®, in both IV and SC forms in November 2023, and Biogen’s IV Tofidence® in June 2024.

On 1 December 2025, Lupin announced that the US FDA has approved Armlupeg™, biosimilar to Amgen’s Neulasta® (pegfilgrastim) in 6 mg/0.6 mL pre-filled syringe (PFS) form.  Just days later, on 4 December 2025, Lupin also announced that it entered into an exclusive licensing agreement with Valorum Biologics for the US commercialisation of Armlupeg™.

Under the terms of the licence agreement, Valorum will be the responsible for commercialisation and distribution of Armlupeg™, while Lupin will be responsible for manufacturing and supply of the product and will receive an upfront licence fee and a royalty payment on net sales.

There are a number of other pegfilgrastim biosimilars approved in the US, including Biocon’s Fulphila® (June 2018), Coherus/Accord’s Udenyca® (November 2018), Sandoz’s Ziextenzo® (November 2019), Pfizer’s Nyvepria® (June 2020), Amneal/Kashiv’s Fylnetra™ (May 2022), and Fresenius’ Stimufend® (September 2022).

The US approval of Armlupeg™ follows approval by Health Canada in August 2024 for the same presentation.

On 4 December 2025, Halozyme announced that the Munich Regional Court has granted its application for a preliminary injunction to prevent MSD from distributing and offering for sale in Germany its Keytruda SC™ (pembrolizumab and berahyaluronidase alfa-pmph).  The decision was based on a finding of the Court that there was imminent infringement of one of Halozyme’s European MDASE™ patents, EP 2797622, in relation to modified PH20 hyaluronidase polypeptides and compositions.  It is not known whether MSD intends to appeal the decision.

According to the Wall Street Journal, MSD has issued a statement saying that MSD considers Halozyme’s patent “to be invalid globally and their allegation of infringement to be without merit”.  MSD commenced legal proceedings against Halozyme’s ‘622 patent in the German Federal Patent Court in August 2025, alleging that it is invalid.  MSD also filed a claim in the UK High Court of Justice in August 2025 seeking revocation of the ‘622 patent.

MSD’s subcutaneous (SC) formulation of Keytruda® was approved in Europe in November 2025, following a positive recommendation from the EMA’s CHMP in September 2025.  The preliminary injunction in Germany will disrupt MSD’s launch plans in relation to Keytruda SC™ in that jurisdiction, although the IV presentation of Keytruda® will still be available.

Halozyme has also sued MSD in the US in relation to SC pembrolizumab (marketed as Keytruda Qlex™ in the US).  In a complaint filed on 24 April 2025, Halozyme alleged that Keytruda Qlex™ infringes 15 patents owned by Halozyme in relation to the MDASE™ subcutaneous delivery platform.  The lawsuit followed reports in March 2025 that  Halozyme had offered MSD an opportunity to licence its MDASE patents.  At the time, a spokesperson from MSD said the enzyme used in Keytruda Qlex™ was “developed independently” from Halozyme and that MSD “strongly believes” that any Halozyme patents that attempt to cover the enzyme variant are invalid.

MSD has filed petitions for post-grant review with the US Patent Trial and Appeal Board challenging the validity of 15 of Halozyme’s US patents.  14 petitions were filed between November 2024 and June 2025 and all have been instituted.  The patents at issue are: US 11952600, US 12018298, US 12152262, US 12123035, US 12110520, US 12054758, US 12060590, US 12049652, US 12104185, US 12037618, US 12091692, US 12077791, US 12195773 and US 12264345.  An additional petition was filed on 10 November 2025 in relation to US12371685 and is currently pending.

On 3 December 2025, Celltrion announced that it received FDA approval for a new 300 mg/2 mL pre-filled syringe presentation of Omlyclo®, biosimilar to Novartis’ Xolair® (omalizumab).  The US approval follows EU approval of the same dosage form in November 2025.

Omlyclo® was first approved in the US in March 2025, in 75 mg/0.5ml and 150mg/ml PFS forms, with full interchangeable status.  It has also been approved in the EU (May 2024), Korea (June 2024), Australia (November 2024), Canada (December 2024), and New Zealand (April 2025).

Celltrion commenced its European rollout of Omlyclo® with the launch of the product in Norway in September 2025, and completed its launch in major European countries including Germany, Spain, the UK and France in November 2025.  In late November 2025, Celltrion announced that it launched Omlyclo® in Brazil, Latin America’s largest pharmaceutical market.

Aurobindo, Teva, Glenmark and Kashiv reportedly also have omalizumab biosimilars under development.  On 11 August 2025, Kashiv BioSciences announced that it entered into a licence and supply agreement with Brazilian pharmaceutical company, CRISTÁLIA, for Kashiv’s biosimilar omalizumab, ADL-018, for the Latin American Market.  Kashiv has previously entered into agreements for commercialisation of ADL-018 in other regions, including with MS Pharma for MENA markets (August 2025) and Alvotech for the EU, UK, Australia, Canada and New Zealand (AVT23, October 2023).  A marketing application for AVT23 was accepted by the UK’s MHRA in March 2025.

On 24 November 2025, Alvotech announced that the European Commission has approved denosumab biosimilar, AVT03, in two presentations referencing Amgen’s Prolia® and Xgeva®.

Alvotech has semi-exclusive commercialisation agreements for European markets with both STADA (June 2024)  and Dr Reddy’s (May 2024) in relation to AVT03.  STADA will market AVT03 as Kefdensis® (referencing Prolia®) and Zvogra® (referencing Xgeva®), while Dr. Reddy’s will market AVT03 as Acvybra® (referencing Prolia®) and Xbonzy® (referencing Xgeva®).

The next day, on 25 November 2025, Teva Pharmaceuticals announced that it also received European Commission approval for its two denosumab biosimilars, Ponlimsi® (referencing Prolia) and Degevma® (referencing Xgeva®).

The flurry of approvals follow the positive opinions adopted by the EMA’s CHMP in September 2025 for STADA’s, Dr Reddy’s and Teva’s denosumab products.

Sandoz’s Wyost® and Jubbonti® were the first denosumab biosimilars approved in Europe (May 2024), and on 1 December 2025, became the first to launch.  There are a number of other denosumab biosimilars already approved in Europe although none have launched to date: Samsung Bioepis’ Obodence™ and Xbryk™ (February 2025), Celltrion’s Stoboclo® and Osenvelt® (February 2025), Accord Healthcare’s Jubereq® and Osvyrti® (May 2025); Gedeon Richter’s Junod® and Yaxwer®, mAbxience’s Izamby® and Denbrayce®, Biocon’s Evfraxy® and Vevzuo® (July 2025), Fresenius Kabi’s Conexxence® and Bomyntra® (July 2025) and Shanghai Henlius/Organon’s Bildyos® and Bilprevda® HLX14) (September 2025).

Regeneron/Bayer and Sandoz have settled Australian aflibercept patent infringement/revocation proceedings, with the Federal Court of Australia on 27 November 2025 dismissing all related proceedings by consent (VID715/2025; VID968/2025; VID1234/2025).  The terms of the AU settlement have not otherwise been disclosed.

Regeneron and Bayer commenced proceedings against Sandoz on 4 June 2025 alleging infringement of Regeneron’s patent AU2012205599 relating to methods of treatment for angiogenic eye disorders, and separately sought preliminary discovery from Sandoz in relation to a second Regeneron aflibercept formulation/process patent, AU2020397865.

Regeneron/Bayer sought both a preliminary injunction (PI or interlocutory injunction) and final relief in respect of AU599, and Sandoz cross-claimed for invalidity.  The PI application was heard on 14 August 2025 with Justice Rofe publishing her reasons for judgment on 8 September 2025, rejecting Regeneron/Bayer’s application.  Rofe J found there was an “insufficient likelihood of success” that Regeneron/Bayer’s infringement case would succeed at a final hearing and that the balance of convenience did not favour the grant of the interlocutory injunction.

Regeneron moved swiftly to appeal her Honour’s decision, with the Full Court hearing the appeal on 29 October 2025.  However, the proceedings were settled the day that judgment was due to be delivered, with no decision being handed down.

Regeneron and Bayer’s ‘599 patent remains the subject of revocation proceedings in Australia.  In August 2025, Actor Pharmaceuticals, which does not yet have any aflibercept biosimilar approved in Australia, filed proceedings in the Federal Court seeking to invalidate AU599, with the first case management hearing in that matter heard on 2 December 2025.  In that first case management hearing, Regeneron’s counsel represented that it is also considering whether to involve the ‘865 patent and bring preliminary discovery proceedings.  Actor’s aflibercept product remains under evaluation by the TGA and is not yet approved.

On 9 September 2025, Sandoz announced that it settled all US patent disputes between it and Regeneron relating to Sandoz’s Enzeevu® (aflibercept).  Under the terms of the US settlement, Sandoz is permitted to launch its biosimilar aflibercept in the US in Q4 2026, or earlier in certain undisclosed circumstances.