On 8 October 2026, Lupin obtained approval in Australia for three generic ranibizumab products (biosimilars to Novartis’ Lucentis®) under three different brand names, Simulara®, Solentis® and Zivra™.  Each brand is approved in two different formats: 2.3mg/0.23mL solution for injection vial and 1.65mg/0.165 mL solution for injection pre-filled syringe.

Lupin’s wholly owned Australian subsidiary, Generic Health, recently applied for PBS listing of the three brands, with the applications to be considered at the November 2026 PBAC meeting.  Interestingly, Sandoz is the registered owner of the Simulara® trade mark (suggesting that Sandoz may launch one of these biosimilars) and originator Novartis is the registered owner of the Solentis® trade mark in Australia and in some overseas countries (suggesting that perhaps Novartis will seek to cannibalise its own ranibizumab market with the launch of a biosimilar in Australia).  There is no Australian registered trade mark application for Zivra™.

Prior to Lupin’s approvals, there were two ranibizumab biosimilars approved in Australia: Actor Pharmaceuticals’ Raniviz® in 1.65mg/0.165mL PFS (TGA-approved February 2026), and Samsung Bioepis’ Byooviz® 10 mg/mL solution for injection vial (approved August 2022).  No biosimilar product has been launched to date in Australia.  Actor has applied for PBS listing of its biosimilar ranibizumab, with that PBS application also to be considered at the November 2026 PBAC meeting at the same time as Lupin’s.  Despite its approval in 2022, Samsung Bioepis’ Byooviz® is not yet PBS-listed, and there is no suggestion that any PBS application has been made to date.

On 7 October 2026, Celltrion announced that the FDA has approved an additional indication for its IV formulation of Avtozma® (tocilizumab), biosimilar to Roche/Genentech’s Actemra®, for the treatment of COVID-19 in paediatric patients aged 2 years and older.  This expands the previous US approved indications for Avtozma®, which included COVID-19 in adults.

Both the intravenous and subcutaneous formulations of Avtozma® were first approved in the US in January 2025, with the IV formulation launched in October 2025.  In August 2025, the FDA approved an additional indication for the IV formulation for the treatment of cytokine release syndrome.  In December 2025, Celltrion secured reimbursement coverage for Avtozma® IV in the US, with patient reimbursement available from January 2026.

Biogen/Bio-Thera’s Tofidence®/BAT1806 (tocilizumab-bavi) was the first US approved tocilizumab biosimilar (IV formulation approved September 2023; launched May 2024), followed by Fresenius Kabi’s Tyenne® (tocilizumab-aazg) (March 2024; IV formulation launched April 2024; SC formulation launched July 2024).

Celltrion’s Avtozma® was the first tocilizumab biosimilar to be approved in Korea in December 2024.  In the same month, Avtozma® received a positive recommendation by the EMA’s CHMP and subsequently gained European Commission approval in February 2025.  The biosimilar has also been granted marketing approval in other regions, including as the first tocilizumab biosimilar approved in Australia (May 2025), Japan (September 2022) and New Zealand (December 2025).  On 1 October 2026, Celltrion’s Avtozma® became the first tocilizumab biosimilar to be listed on Australia’s Schedule of Pharmaceutical Benefits, after being recommended for PBS-listing at the November 2025 PBAC meeting.

On 7 October 2026, Halozyme Therapeutics announced that it has won an injunction from the specialised Dutch patent court of The Hague, preventing MSD from manufacturing, selling, importing and stockpiling Keytruda SC™ (pembrolizumab and berahyaluronidase alfa-pmph) in Belgium, Denmark, France, Ireland, Italy, Sweden, Switzerland and the Netherlands.

The Court ordered the injunction based on its finding that Halozyme’s patent, EP 297 622 (EP 622) is valid and infringed by MSD.  EP 622 relates to modified PH20 hyaluronidase polypeptides and compositions, which Halozyme claims allow for rapid subcutaneous administration of therapeutic drugs.

MSD’s subcutaneous pembrolizumab formulation uses Alteogen’s ALT-B4 technology, a recombinant human hyaluronidase enzyme platform (berahyaluronidase alfa) designed to convert intravenous (IV) drugs into subcutaneous formulations.  Under licensing terms with MSD, Alteogen obtains milestone payments and ongoing commercial royalties linked to Keytruda SC™ sales.  However, according to Korea Economic Daily, Alteogen expects little financial impact from the Dutch court ruling, with the outcome estimated to affect only 3% of Keytruda SC™’s global market.

The final injunction granted by the Dutch Court follows a ruling of the District Court of The Hague in July 2026 dismissing Halozyme’s application for a preliminary injunction to prevent MSD from marketing Keytruda SC™ in Denmark and Sweden pending the outcome of the substantive proceedings.

MSD and Halozyme are also in dispute elsewhere over patents to Halozyme’s MDASE™ subcutaneous delivery technology.  In December 2025, the Munich Regional Court granted a preliminary injunction, preventing MSD from distributing and offering for sale in Germany Keytruda SC™, based on a finding of the Court that there was imminent infringement of EP 622.

In April 2024, Halozyme sued MSD in the US, alleging that MSD’s subcutaneous pembrolizumab (Keytruda Qlex®) infringes 15 patents.  As of 7 October 2026, MSD had successfully invalidated claims of 9 of Halozyme’s US patents before the Patent Trial and Appeal Board (PTAB) and had a further 8 petitions pending before PTAB.

MSD’s subcutaneous pembrolizumab was approved in Europe in November 2025.  It has also been approved in the US as Keytruda Qlex™ (September 2025); in Canada (February 2026), Korea (May 2026, launched September 2026) and Australia (July 2026), as Keytruda SC™; and in Japan as Keyject™ (September 2026).

While there are no reports of biosimilar subcutaneous pembrolizumab development to date, there are multiple pembrolizumab (IV) biosimilars approved or in development.  For example, Samsung Bioepis and Celltrion each applied for Korean approval of their pembrolizumab biosimilars in August 2026 (SB27 and CT-P51, respectively).  In June 2026, Samsung Bioepis claimed to be the first developer of a pembrolizumab biosimilar to announce global phase 3 trial results.  Amgen also confirmed on 15 September 2026 that its Keytruda® biosimilar has successfully completed clinical trials with an FDA submission likely later this year.  Formycon announced successful Phase 1 results in February 2026, with its US commercialisation partner, Zydus, expressing optimism that it is well-placed to file the first BLA in the US for biosimilar pembrolizumab.

On 6 October 2026, Celltrion announced the US launch of Omlyclo®, biosimilar to Genentech/Novartis’ Xolair® (omalizumab).  Omlyclo® is the first omalizumab biosimilar on the US market and is available in three dosage forms: 75 mg, 150 mg and 300 mg.

Omlyclo® was launched in the US at a wholesale acquisition cost (WAC) approximately 15% lower than that for the reference product, Xolair®.  It is listed as a preferred drug in the private insurance prescription book of Optum, a major US Pharmacy Benefit Manager (PBM).  According to Celltrion, it is also in negotiations with other PBMs.

Omlyclo® was first approved in the US in March 2025, in 75 mg/0.5ml and 150mg/ml PFS forms, with full interchangeable status.  The 300 mg formulation was FDA approved in December 2025.

The European launch of Omlyclo® in 75 mg and 150 mg dosage forms commenced in September 2025 and was completed in November 2025.  The high dose (300 mg) dosage form was launched in Europe in August 2026.  Omlyclo® to date remains the only omalizumab biosimilar approved in the EU, with Celltrion receiving EU market authorisation for its 75 mg/0.5 mL and 150 mg/1 mL PFS formulations in May 2024, and approval for the 300 mg formulation in November 2025

Omalizumab biosimilars in development include Kashiv BioSciences/Alvotech’s ADL-018/AVT23, with an application for ADL-018 accepted for review by Health Canada in June 2026 and marketing applications for AVT23 accepted by the UK’s MHRA in March 2025 and the European Medicines Agency in October 2025.  Under an exclusive licensing agreement with Kashiv entered in October 2023, Alvotech holds the commercialisation rights to ADL-018/AVT23 in Canada, together with the European Economic Area, UK, Switzerland, Australia and New Zealand.  Kashiv has entered into agreements for commercialisation of ADL-018 with Cristália for LATAM (August 2025) and MS Pharma for MENA markets (August 2025).

Teva’s biosimilar omalizumab applications have been accepted for review in the US and EU (March 2026) and CuraTeQ announced Phase 3 study results for its biosimilar omalizumab, BP11, in April 2026.  Mabpharm claims to have had an omalizumab biosimilar (Aomaishu®) approved for marketing in China in May 2023.

On 6 October 2026, Alvotech announced that it has entered into a strategic manufacturing partnership for biosimilars with Lotte Biologics. a contract development and manufacturing organisation (CDMO) that provides end-to-end services for complex pharmaceutical products.

Under the agreement, Lotte Biologics will manufacture multiple unidentified biosimilar products at its Syracuse facility in New York for global supply, with the potential to expand the collaboration over time.

Lotte’s Syracuse facility, which was acquired from BMS in January 2023, has 40,000 litres of bioreactor capacity for biologics manufacturing, supported by on-site process development and quality control capabilities.  According to Alvotech, the expansion of its global manufacturing network, including through the agreement with Lotte, will provide sufficient capacity to meet demand for its pipeline for the next ten years.

The agreement with Lotte follows FDA approval for Alvotech to manufacture its adalimumab biosimilar in a second production suite in Alvotech’s Reykjavik facility, effectively doubling its manufacturing capacity for the US market.

On 6 October 2026, Israel-headquartered biopharmaceutical company Kamada announced the launch of two new biosimilar products in Israel: Ustekinumab-Kamada, biosimilar to Janssen’s Stelara®, and Enoxaparin-Kamada, biosimilar to Sanofi’s Clexane®.

The launch of the two biosimilars has doubled Kamada’s biosimilar portfolio.  Kamada launched Bevacizumab-Kamada, biosimilar to Roche’s Avastin®, and Pegfilgrastim-Kamada, biosimilar to Amgen’s Neulasta®, in Israel over the last two years.  All four biosimilar products were approved and launched as interchangeable with the reference product.

According to Kamada, by 2030, it expects its biosimilar portfolio to include at least 12 marketed products in Israel and MENA, licensed from 6 different leading international biosimilar companies.

Both Janssen and Sanofi face significant competition globally from ustekinumab and enoxaparin biosimilars (respectively), including growing competition in MENA.  Notably, in December 2024, Formycon and MS Pharma announced that they have entered into a licence and supply agreement for commercialisation of Formycon’s ustekinumab biosimilar (FYB202) in MENA.  Earlier, in December 2022, Hikma Pharmaceuticals announced that it signed an exclusive licence agreement with Celltrion for its ustekinumab biosimilar (CT-P43), giving Hikma exclusive rights to market Celltrion’s product in all of Hikma’s MENA markets.

On 6 October 2026, Nordic-based Orion Pharma announced that it has entered into a European commercialisation agreement with China-headquartered Qilu Pharma, for Qilu’s intravenous QL2107, biosimilar to MSD’s Keytruda® (pembrolizumab).

Under the agreement, Orion has the exclusive right to distribute, market and sell Qilu’s biosimilar pembrolizumab in Europe, while Qilu will supply the product to Orion and is entitled to receive certain confidential development and regulatory milestone payments.

This follows the September 2026 announcement that Qilu has partnered with InvaGen Pharmaceuticals Inc., a wholly owned subsidiary of Cipla Limited, for the US commercialisation of QL2107 (pembrolizumab).

In January 2025, Qilu initiated a Phase 3 study for QL2107, to compare the efficacy and safety of QL2107 vs Keytruda® in combination with chemotherapy in treating metastatic non-squamous non-small-cell lung cancer.  The study has an estimated primary completion date of December 2026.

There are multiple pembrolizumab (IV) biosimilars approved or in development.  Samsung Bioepis and Celltrion each applied for Korean approval of their pembrolizumab biosimilars in August 2026 (SB27 and CT-P51, respectively).  In June 2026, Samsung Bioepis claimed to be the first developer of a pembrolizumab biosimilar to announce global phase 3 trial results.  Amgen also confirmed on 15 September 2026 that its Keytruda® biosimilar has successfully completed clinical trials with an FDA submission likely later this year.  Formycon announced successful Phase 1 results in February 2026, with its US commercialisation partner, Zydus, expressing optimism that it is well-placed to file the first BLA in the US for biosimilar pembrolizumab.

Pembrolizumab biosimilars have reportedly been launched in Paraguay (by Bioeticos in August 2025) and approved in Vietnam (by Biocad in November 2025) and Jordan (by Sana Pharma in February 2026).  Pembrolizumab biosimilars are also in clinical trials including by mAbxience, Sandoz, Bio-Thera, Shanghai Henlius, BioNTech and Enzene.

On 5 October 2026, Alvotech announced that the FDA has approved its supplement to the Biologics License Application for AVT02 (marketed as Simlandi® in the US), biosimilar to AbbVie’s Humira® (adalimumab). This approval allows drug manufacturing in a second production suite in Alvotech’s Reykjavik facility and will effectively double the manufacturing capacity available to support Alvotech’s biosimilar adalimumab supply in the US.

According to Alvotech, the FDA’s approval “further confirms” resolution of FDA inspection related matters at the Reykjavik site.  A July 2025 inspection had found deficiencies at the site, with the FDA then rejecting Alvotech’s golimumab (AVT05), aflibercept (AVT06), and denosumab (AVT03) BLAs in November 2025, December 2025 and January 2026, respectively.  After conducting a “remediation project” to address the FDA’s comments, Alvotech resubmitted its BLAs to the FDA in June 2026.  In July 2026, the FDA closed its inspection of the Reykjavik site with a Voluntary Action Indicated (VAI) classification (meaning objectionable conditions or practices were found, but the FDA did not take or recommend any administrative or regulatory action).

Alvotech expects the FDA to take action on its pending applications associated with the Reykjavik facility according to their respective goal dates, including for AVT16, biosimilar to Entyvio® (vedolizumab), which is currently the subject of pending BPCIA litigation.

On 1 October 2026, Fresenius SE announced that it has completed its acquisition of Spanish-based mAbxience by acquiring the remaining 45% stake in the company, having taken a 55% majority stake in 2022.  The acquisition was completed for up to €750 million, including a contingent payment of €50 million upon site-approvals.

mAbxience’s biosimilar platform is now wholly owned within Fresenius Kabi’s biopharma business, creating a vertically integrated business covering the full value chain from development and manufacturing to commercialisation.

mAbxience’s biosimilars to Amgen’s Prolia® and Xgeva® (denosumab), were approved in the US in December 2025 (as Boncresa™ and Oziltus™) and in Europe in July 2025 (as Izamby® and Denbrayce®).  Last month, mAbxience entered into a licensing, development, manufacturing and commercialisation agreement with Sandoz for a biosimilar to Roche/Chugai’s Hemlibra® (emicizumab).

On 1 October 2026, Celltrion’s Avtozma® (tocilizumab), biosimilar to Genentech’s Actemra®, became the first tocilizumab biosimilar to be listed on Australia’s Schedule of Pharmaceutical Benefits (PBS).  The PBS listing of Avtozma® will result in a mandatory 25% statutory price reduction for Actemra®.

Avtozma® was the first, and remains the only, tocilizumab biosimilar to be approved in Australia (May 2025).  It was launched in Korea in June 2025. in the US (IV formulation) in October 2025, and in Europe in January 2026.  The biosimilar has also been granted marketing authorisation in a number of other regions, including Japan (September 2022) and New Zealand (December 2025).

Celltrion additionally had the following products listed on the PBS on 1 October 2026:

• Yuflyma® (adalimumab), biosimilar to AbbVie’s Humira®, in a 20 mg/0.2 mL injection, 2 x 0.2 mL syringes format. Yuflyma® was approved by the TGA in this format in September 2024; and
• Omlyclo® (omalizumab), biosimilar to Genentech’s/Novartis’ Xolair®, for hospital use in 75 mg/0.5 mL injection, 0.5 mL pen device and 150 mg/mL injection, 1 mL pen device formats. Omlyclo® was approved by the TGA in each of these formats in November 2024/August 2025.