On 24 June 2025, Biocon Biologics announced it has partnered with the National Cancer Society of Malaysia (NCSM), a non-for-profit organisation, to launch a Patient Assistance Program advocating for the accessibility and affordability of biosimilars.  Biocon intends to supply the NCSM with a range of biosimilars from its oncology portfolio, including trastuzumab, pegfilgrastim and bevacizumab.  The program will commence with provision of bTrastuzumab to cancer patients currently facing treatment delays due to budget constraints.

In the US, Biocon’s oncology franchise includes Ogivri® (biosimilar trastuzumab, launched in December 2019), Fulphila® (biosimilar pegfilgrastim, approved June 2018) and Jobevne™ (biosimilar bevacizumab, approved April 2025).

On 30 April 2025, Roche announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending an update to the European Union (EU) label for Phesgo® to allow administration outside of a clinical setting, such as in a person’s home, by a healthcare professional.  Phesgo® is a subcutaneous fixed-dose combination of Perjeta® (pertuzumab) and Herceptin® (trastuzumab), used to treat human epidermal growth factor receptor 2 (HER2)-positive breast cancer.

Earlier this month, in its 2025 first quarter earnings call, Roche described its biosimilar exposure for its Perjeta® (pertuzumab) as “relatively limited” and “not a threat that we’re super worried about right now,” considering the lack of potential competitors in late-stage development or filing.  Roche believes that the most-advanced pertuzumab biosimilar, Henlius’ HLX11, is unlikely to enter the market until at least late 2027.

HLX11 is currently under consideration for regulatory approval in the EU (March 2025), US (February 2025) and China (December 2024).  In June 2022, Henlius entered into a licence agreement with Organon regarding HLX11 (and HLX14), under which Organon has exclusive global commercialisation rights to the biosimilars for all countries except China, Hong Kong, Macau and Taiwan.

At its April meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Aurobindo Pharma’s subsidiary CuraTeQ’s Dazublys® (150 mg powder for concentrate for solution for infusion), biosimilar to Roche’s Herceptin® (trastuzumab).  The biosimilar is indicated for HER2-positive metastatic and early breast cancers.  According to Aurobindo, European Commission approval is expected in July 2025.

The first trastuzumab biosimilar was approved in the EU in November 2017 and in the US in December 2017.

On 8 November 2024, Celltrion announced that it has achieved accumulated sales for Q3 2024 of KRW 2.4 trillion, surpassing its 2023 annual sales.  Its quarterly sales are the highest it has ever reported, up 31.2% year on year.

Celltrion attributes its sales growth to the expansion of global prescriptions for its subcutaneous infliximab, Remsima SC® (EU, launched in 2020)/Zymfentra™ (US, launched in March 2024), biosimilar adalimumab.  Yuflyma® (80mg dose US launch January 2024, 40mg dose first approved by the FDA in May 2023, launched 2023, paediatric form US launch March 2024), and biosimilar bevacizumab, Vegzelma® (US launch April 2023).  It has also experienced steady growth in its anticancer products, Truxima® (rituximab, US launch May 2020) and  Herzuma® (trastuzumab, US launch March 2020).

During 2024, Zymfentra™ secured all six public and private insurance contracts operated by the three major prescription drug managers (PBMs) in the US.  Celltrion estimates that it has now secured more than 90% coverage in the US insurance market by completing contracts with 30 mid- to large-sized and regional PBMs and insurance companies.

Celltrion also notes the expansion of its biosimilar portfolio during 2024 with the launch of SteQeyma® (ustekinumab) in major European countries on 1 November.  Celltrion is planning for the 2025 launch of Eydenzelt® (CT-P42, aflibercept).

Celltrion has a number of biosimilars under development, including CT-P41 (denosumab, US aBLA filed December 2023),  CT-P47 (tocilizumab), CT-P55 (secukinumab), CT-P53 (ocrelizumab) and CT-P51 (pembrolizumab).

On 30 October 2024, Biocon Limited announced its financial results for Q3 2024, reporting that while its total consolidated revenue was flat (year on year), it experienced “robust performance” in its biosimilars business with growth of 19% (year on year).  Biocon attributes the biosimilar growth to an increase in market share in the US, expansion in Europe and 15 new launches in emerging markets.

Biocon reports that its oncology franchise, including Ogivri® (biosimilar trastuzumab, US launch in December 2019) and Fulphila® (biosimilar pegfilgrastim, US approval in June 2018), has experienced an increase in market share over the quarter (YoY), with the market share for Ogivri® increasing from 11% to 18% and that for Fulphila® increasing from 15% to 21%.  Biocon’s insulin products have also grown in market share with unbranded bGlargine and Semglee® (insulin glargine-yfgn) surpassing 15%.

Biosimilar highlights for the third quarter include the EMA’s validation of Biocon’s application for biosimilar denosumab and Biocon’s settlement and licence agreement in August 2024 for Yesintek™ (Bmab 1200), biosimilar to Janssen’s Stelara® (ustekinumab), permitting Biocon to launch in Europe, the UK, Canada and Japan following regulatory approval.  Biocon had previously entered a settlement agreement with Janssen in relation to ustekinumab in May 2024, allowing US launch in February 2025.  The FDA accepted Biocon’s BLA for Bmab 1200 for review under the 351(k) pathway in May 2024.

In emerging markets, Biocon specifically refers to launches of biosimilar bevacizumab and pegfilgrastim in Saudi Arabia and regulatory approvals for biosimilars of bevacizumab, etanercept, adalimumab, insulin aspart and rh-insulin in several countries in the Latin American, African and Middle East regions.

Biocon’s licensing and supply agreement with Tabuk Pharmaceutical for commercialisation of its GLP-1 products for diabetes and chronic weight management in certain Middle East countries and its exclusive distribution and supply agreement with a leading pharmaceutical company in Brazil (October 2024) for commercialisation of liraglutide (generic of Novo Nordisk’s Victoza®/Saxenda®) are also said to be Q3 2024 highlights.

On 18 September 2024, Accord BioPharma announced that the FDA has approved a 420mg strength of its Hercessi™ (trastuzumab-strf), biosimilar to Roche’s Herceptin®, for HER2-overexpressing breast and gastric or gastroesophageal junction adenocarcinoma.

Hercessi™ was FDA-approved in a 120mg dosage form in April 2024.  Accord plans to launch Hercessi™ in the US in early 2025 as the company’s first biosimilar.

Hercessi™ (HLX02) was developed by Shanghai Henlius Biotech, with Henlius granting Accord the exclusive rights to develop and commercialise the trastuzumab biosimilar in the US and Canada in 2021.  Canadian approval for the biosimilar, where it is marketed as Adheroza™, was granted in August 2024.

HLX02 (150mg) was approved in Australia in July 2022 (marketed by Cipla under the names Tuzucip™ and Trastucip™).  It has been sold as Zercepac™ in Europe (approved July 2020) and HANQUYOU in China (approved August 2020).

The first trastuzumab biosimilar was approved in the US in December 2017 and in the EU in November 2017.

On 13 September 2024, Celltrion announced it has won the contract to supply Herzuma® (trastuzumab), biosimilar to Roche’s Herceptin®, to the Brazilian Federal Government to the end of 2025.  Celltrion will supply 660,000 vials of the biosimilar during the fifth consecutive year that it has held the government contract.  It claims that Herzuma® is the most prescribed trastuzumab drug in Brazil and accounts for more than 50% of the market annually.

Celltrion also reports that it recently succeeded in winning the bid to supply Remsima® (infliximab), biosimilar to J&J’s Remicade®, to the Brazilian Federal Government for the third consecutive year.  Last month, it was asked to supply 25% more vials of the drug than originally contracted.

This follows Celltrion’s recent tender successes regarding Remsima® and Herzuma® in Peru (May 2024) and Remsima SC® in Denmark (April 2024), Norway (February 2024) and Sicily (January 2024).  In February 2024, Celltrion also secured a series of tenders in Peru to supply Herzuma® (trastuzumab biosimilar), Truxima® (rituximab biosimilar) and Yuflyma® (adalimumab biosimilar).  In June 2024, Celltrion successfully applied to be the exclusive supplier of Remsima®, Herzuma® and Vegzelma® (bevacizumab biosimilar) to France’s largest pharmaceutical procurement group (Union des Hopitaux pour les Achats (UniHA)), until 2027.

On 6 September 2024, Celltrion’s CEO, Seo Jin-seok, announced at the 22^nd Morgan Stanley Global Healthcare Conference that it plans to obtain approval for 11 biosimilar products by 2025, with an aim to have a “portfolio of 22 products by 2030”.

Celltrion has 8 biosimilars approved in various jurisdictions, namely omalizumab, ustekinumab, adalimumab, aflibercept, rituximab, trastuzumab, bevacizumab, and SC infliximab, and has biosimilar pembrolizumab, secukinumab and denosumab in clinical trials.

According to a report by Korea Economic Daily on 12 September 2024, Celltrion also has plans to establish and build a wholly owned contract development and manufacturing organisation (CDMO) plant with a capacity of 180,000 litres and production lines for antibody-drug conjugates, including Zymfentra^™/Remsima SC® (SC infliximab).

Shanghai Henlius Biotech has revealed its financial results for the first half of 2024, reporting revenue of RMB2.7461 billion (an increase of 9.8% YOY) and a record net profit of RMB2.7461 million (an increase of 61% YOY).

Henlius attributes its profits to increasing commercial sales of its core products; namely, its trastuzumab biosimilar HANQUYOU/HLX02 (known as Hercessi^TM in the US and Zercepac® in Europe) and HANSIZHUANG (serplulimab), its treatment for small-cell lung cancer, which has been launched in China, Indonesia, Cambodia and Thailand.  Henlius reports that its MAA for HANSIZHUANG has been validated by the European Medicines Agency (EMA) and is expected to be approved in 2024.  Henlius plans to submit a BLA for the product in the US in early 2025.

Other milestones noted by Henlius include the approval of HANLIKANG (biosimilar rituximab) in Peru and acceptance of its European MAA for HLX14 (biosimilar denosumab) in May 2024.  Henlius plans to submit marketing applications for HLX14 in the US, and for HLX11 (biosimilar pertuzumab) in the US and China, in the second half of 2024.

In June 2022, Shanghai Henlius entered into a licence agreement with Organon regarding HLX14 and HLX11 under which Organon has exclusive global commercialisation rights for all countries except China, Hong Kong, Macau and Taiwan.

On 22 August 2024, Shanghai Henlius Biotech announced that its partner, Intas subsidiary Accord Healthcare, has received marketing approval from Health Canada for HLX02, the Henlius-developed biosimilar to Roche’s Herceptin® (trastuzumab) to treat early/metastatic breast cancer and metastatic gastric cancer.  HLX02 is marketed in Canada under the name Adheroza.

HLX02 (150mg) was approved in the US as Hercessi™ in April 2024 and in Australia in July 2022 (marketed by Cipla under the names Tuzucip™ and Trastucip™).  It has been sold as Zercepac™ in Europe (approved July 2020) and HANQUYOU in China (approved August 2020).

The first trastuzumab biosimilar was approved in the US in December 2017 and in the EU in November 2017.